Podcasts about regulatory

Dan Romero, who leads go-to-market at Tempo, joins Sam Ewen with a 12-year crypto perspective that stretches from the early days at Coinbase to building Farcaster to now focusing entirely on stablecoin payment rails. He breaks down why these three things: regulation, infrastructure, and distribution, have finally aligned to make real world crypto adoption possible, and why Tempo's betting on being the best payments chain rather than a general purpose blockchain. - Timecodes: 0:00 – Intro on stablecoin yield philosophy 1:20 – From Farcaster to Tempo: the through line 2:56 – The market split: speculation vs. stablecoins 5:37 – Regulatory tailwinds from the Genius Act 8:41 – How yield on Tempo works 14:23 – Balancing privacy and transparency 17:38 – What it takes to win in payments infrastructure 21:01 – Why compliance matters 22:25 – Outlook on the Genius Act rulemaking - From our sponsors: Ledn provides a secure and transparent way to access liquidity while maintaining your bitcoin holdings. Perfect 8 year track record of keeping clients assets safe. Don't sell your bitcoin. Get a bitcoin-backed loan. Check out your rate by using their loan calculator at ledn.io - This episode is brought to you by RealFi, a smarter stablecoin, backed by real-world assets. Find out more at realfi.co. - Check out CoinDesk Research's report on Zcash's push toward private scale and quantum resilience at: https://www.coindesk.com/research/building-the-zcash-machine-tachyon-and-quantum-readiness - "Spotlight" features host Sam Ewen.

This bonus episode expands on the themes discussed in Episode 5 by providing a practical example of how energy resilience strategies are implemented at the local level. The discussion focuses on Switzerland's requirements for large energy consumers, organisations that exceed defined thresholds for electricity or heat consumption and are therefore subject to specific obligations to improve energy efficiency and reduce emissions. The guests explain the regulatory pathways available, including target agreements, energy audits, and cantonal agreements, highlighting how requirements can vary across Switzerland's 26 cantons. Ultimately, the case study reinforces a central theme of the series: global challenges require locally informed solutions, and energy resilience depends on balancing regulatory compliance, operational efficiency, and long-term sustainability goals. Guest quotes: Mariarosaria Gagliotti: “By meeting the definition of a large energy consumer, the company is obligated to take action, implementing reasonable measures to optimise energy consumption.” Sofiane Kessouar: “The LEED certification provides a framework for designing, constructing and operating highly efficient and cost-saving green buildings.” Timestamps: 00:00:00 – Introduction to the Swiss energy resilience case study 00:01:11 – Defining large energy consumers in Switzerland 00:02:13 – Legal obligations for energy efficiency and emissions reduction 00:02:31 – Regulatory compliance pathways and available options 00:03:31 – Choosing the most appropriate compliance strategy 00:04:09 – Single-site versus multi-site considerations 00:04:54 – Understanding Switzerland's cantonal structure 00:05:22 – Local regulations and sustainable construction leadership 00:05:55 – Introduction to LEED certification 00:06:31 – Benefits of green building standards 00:07:06 – Key LEED certification categories 00:07:39 – Lower operating costs and environmental benefits 00:07:57 – Reflections on local expertise and real-world case studies 00:08:06 – Closing remarks and the value of global collaboration Sponsor Copy Rethinking EHS is brought to you by the Inogen Alliance. Inogen Alliance is a global network of 70+ companies providing environment, health, safety, and sustainability services, working together to provide one point of contact to guide multinational organizations to meet their global commitments locally. Visit inogenalliance.com to learn more. --- Links https://Inogenalliance.com/resources https://Inogenalliance.com/podcast Produced by Madcontent.co.nz  

In this episode, Alexander Cutler, CEO of Dromos Labs, shares insights on DeFi, Layer 2 solutions, and the future of on-chain finance, focusing on the success of Aerodrome and Velodrome on Base and Ethereum. Discover how strategic choices and innovative tokenomics are shaping the future of decentralized exchanges and the broader on-chain economy.Check Out Scribe: Scribe.how/CRYPTO101Check out Quince: https://quince.com/CRYPTO101Check out Shopify: https://shopify.com/crypto101Check out NPR: https://npr.orgGet my #1 altcoin pick for this month.Get immediate access to my entire crypto portfolio for just $1.00 today! Get your FREE copy of "Crypto Revolution" and start making big profits from buying, selling,Get immediate access to my entire crypto portfolio.. just $1.00 today! Go here to get access: https://www.crypto101insider.com/cryptnation-directm6pypcy1?utm_source=Internal&utm_medium=YouTube&utm_content=Podcast&utm_term=20250916Get your FREE copy of "Crypto Revolution: Your Guide To The Future of Money". In this book, I reveal how to make (and keep) a fortune during this crypto bull run! http://www.cryptorevolution.com/free?utm_source=Internal&utm_medium=YouTube&utm_content=Podcast&utm_term=20250916Chapters00:00 Introduction and guest background01:30 The evolution of Dromos Labs and platform choices04:00 Alexander's journey into crypto and DeFi07:00 Success story of Velodrome and Aerodrome on Optimism and Base14:05 The strategic focus on Base and Ethereum17:49 Layer 2 solutions and their role in Ethereum's future23:03 The vision of 10% of global GDP on-chain28:01 Regulatory clarity and institutional adoption34:01 Security, decentralization, and protocol design46:58 The Aero tokenomics and revenue flywheel53:57 Upcoming updates and closing remarksSubscribe to YouTube for Exclusive Content:https://www.youtube.com/@crypto101podcast?sub_confirmation=1Follow us on social media for leading-edge crypto updates and trade alerts:https://twitter.com/Crypto101Podhttps://instagram.com/crypto_101*This is NOT financial, tax, or legal advice*Boardwalk Flock LLC. All Rights Reserved  ▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬Fog by DIZARO https://soundcloud.com/dizarofrCreative Commons — Attribution-NoDerivs 3.0 Unported — CC BY-ND 3.0 Free Download / Stream: http://bit.ly/Fog-DIZAROMusic promoted by Audio Library https://youtu.be/lAfbjt_rmE8▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬Our Sponsors:* Check out NPR: https://npr.org* Check out Quince and use my code quince.com/crypto101 for a great deal: https://www.quince.com* Check out Scribe and use my code Scribe.how/CRYPTO101 for a great deal: https://scribe.com/Crypto101* Check out Shopify and use my code shopify.com/crypto101 for a great deal: https://www.shopify.comAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Dr. ⁠Basant Bajpai⁠ CEO of ⁠Compliance MedQRA⁠, a UAE-based consulting company specializing in Quality Assurance, Regulatory Affairs, AI governance and compliance for medical devices, SaMD, AI/ML health technologies and digital health solutions. He holds a PhD in Neuroscience focused on brain monitoring and neurotechnology and has more than 12 years of international experience supporting MedTech and digital health companies across Europe, the Middle East and the United States.He explains why regulatory and quality is still one of the most misunderstood functions in MedTech and why so many innovators treat it as a documentation exercise until it becomes an expensive problem at the worst possible moment. We get into the question every founder asks, how long will this take and what will it cost and why there is genuinely no straight answer without first building a proper regulatory strategy.We also tackle the growing trend of companies choosing the US over EU MDR simply because it looks faster. Basant makes the case that regulatory approval alone does not guarantee commercial entry, why reimbursement codes should shape your market choice more than approval timelines and why he now finds EU MDR more convenient than many people expect. He also shares a contrarian view on device classification and why staying in the lowest risk class is not always the smart play.Finally, we explore the GCC regulatory landscape, which Basant argues is not less regulated but differently regulated, with data compliance requirements he found tougher than GDPR or HIPAA. He closes with a clear message on AI in healthcare and why he does not believe regulators will ever allow a clinician to be replaced.Timestamps[00:01:23] From Biomedical Engineering to a First Audit That Changed Everything[00:03:33] Why Everyone Thinks Regulatory Is Just a Documentation Department[00:06:07] How Long Will It Take and What Will It Cost: The Impossible Question[00:09:35] EU MDR vs FDA: Why Reimbursement Should Drive the Decision[00:12:19] Regulatory Approval Does Not Guarantee Commercial Success[00:14:36] Why Staying in the Lowest Risk Class Can Backfire[00:16:00] The GCC: Not Less Regulated, Just Differently Regulated[00:18:24] Why Data Compliance in the Gulf Is Tougher Than GDPR[00:23:30] Who Should Not Pursue a Career in Quality and Regulatory[00:29:17] Final Advice: AI Will Transform Healthcare but Not Replace CliniciansConnect with Basant - https://www.linkedin.com/in/basant-bajpai-phd-63565961Learn more about Complaince MedQRA - https://www.compliancemedqra.net/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Join hosts Paul Nathanson, Caitlin Sickles, and Omar Nashashibi as they discuss the sudden passing of Senator Lindsey Graham, his legacy, and his unique ability to be one of the few lawmakers who consistently had the president's ear. The team also examines Republican efforts to advance Reconciliation 3.0 and breaks down key items in the White House's latest regulatory agenda affecting manufacturers.

More on VPM.org:  NextEra–Dominion merger filings start 6-month clock on regulatory review  Mending a torn safety net: an investigation into Nelson County social services    Other links:  Report finds ‘substantial disparities' in Virginia Beach contracts with minority-owned businesses (Virginian-Pilot)*  How a Roanoke school's new playground is neurodevelopmentally inclusive (Roanoke Times)*  House committee questions Va. prosecutor in closed-door deposition (Washington Post)*  About time? Richmonders weigh-in on possible permanent daylight saving time (WTVR)  GOP Senate hopefuls face long odds in race to challenge Mark Warner (Virginia Mercury)  Mending a torn safety net: lagging salaries, lapsed communication at Nelson DSS (WMRA)  Mending a torn safety net: systemic challenges in social services (WMRA)  *This outlet uses a paywall.  Our award-winning work is made possible with your donations. Visit vpm.org/donate to support local journalism. 

For many medical device startups, obtaining FDA clearance seems like a clear, linear process.Identify a predicate device.Prepare your documentation.Submit your application.Wait for clearance.In reality, the journey is rarely that simple.In this episode of the Medical Device Made Easy Podcast, Joanna Nathan, CEO of Prana Surgical, shares her firsthand experience navigating the FDA clearance process and discusses the challenges that many startups only discover after they begin.Topics CoveredThe Reality Behind FDA ClearanceWhen do founders realize the process is more complex than expected?What would they do differently if they could start again?Predicate Devices and Substantial EquivalenceChoosing the right predicate device is one of the most important strategic decisions in a 510(k) submission.We discuss:Predicate device selectionIntended use considerationsTechnological characteristicsCommon misconceptions about substantial equivalenceBuilding a Product with the FDA in MindThe conversation explores how early regulatory decisions influence:Product developmentTesting strategyDocumentationRisk managementManufacturing planningWorking with the FDAHow valuable are Pre-Submission (Q-Sub) meetings?What questions should manufacturers ask?What mistakes should they avoid before engaging with the FDA?Lessons Every Startup Should KnowJoanna shares practical advice on:Unexpected FDA questionsCommon causes of delaysSoftware validationBiocompatibilityUsability studiesDocumentation preparationThe biggest misconceptions surrounding FDA clearanceKey TakeawayFDA clearance is much more than completing regulatory paperwork.Successful companies integrate regulatory thinking into product development from the very beginning.Making the right strategic decisions early can save significant time, reduce costs, and improve the likelihood of a successful FDA submission.Whether you're launching your first medical device or preparing your next regulatory submission, this episode provides practical insights to help you navigate the FDA clearance journey with greater confidence.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkJoanna's LinkedIn: https://www.linkedin.com/in/joannacnathanPrana System: https://www.pranasurgical.com/prana-systemPrana Surgical's LinkedIn: https://www.linkedin.com/company/pranasurgicalSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Sesh looks like a consumer brand. 8VC looks like the last fund that would back it. That mismatch is the fastest way to see what Austin is becoming.Sesh founder Max Cunningham and 8VC's Jake Medwell start with the logic that makes the deal make sense. Sesh holds a legal moat most competitors can't cross for years, and it earns software-like margins on a physical product. From there the conversation opens into a bigger question about where ambitious companies belong, and why more of them are choosing a city that now draws the founders and families betting on that future.Agenda00:00 What Sesh is06:05 Why 8VC backed a nicotine company10:44 Regulatory timing and the six-year door16:37 Software margins and owning the factory22:01 Who buys this and why the market is growing29:27 Why some companies need SF and others do not34:32 What Austin talent looks like now42:10 The Elon spillover and the coming IPO wave 48:37 Raising kids in the AI age55:07 Safety, schools, and what comes nextGuest LinksSesh: Max Cunningham, Website, X, Instagram8VC: Jake Medwell, Website, X -------------------Austin Next Links: Website, X/Twitter, YouTube, LinkedInEcosystem Metacognition Substack

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the latest advancements shaping the future of drug discovery and patient care. Veradermics is making significant strides with its oral minoxidil formulation aimed at addressing female pattern hair loss. The mid-stage clinical trial results have analysts optimistic about Veradermics' potential to capture a significant portion of this underserved market. The oral form of minoxidil, traditionally used in topical Rogaine products, offers a novel delivery method that could enhance patient adherence and improve outcomes, marking an innovative leap in dermatological treatments. Johnson & Johnson is navigating the expiration of Stelara's patent protection with resilience, as Tremfya steps up to fill the revenue gap. With quarterly sales exceeding $2 billion, Tremfya underscores the critical role of strategic lifecycle management and robust product pipelines in weathering patent cliffs. This success highlights the necessity for pharmaceutical companies to sustain growth through a well-rounded portfolio that can absorb such impacts. In oncology, Celcuity has achieved a pivotal milestone with FDA approval for its small molecule inhibitor targeting breast cancer. This therapy promises blockbuster potential and could become a new standard-of-care, expanding treatment options for patients. The approval reflects ongoing innovation in oncology, where small molecules continue to play an essential role alongside biologics in advancing cancer therapies. AI-driven drug discovery is gaining traction as Insilico Medicine partners with CDMO Bora in a potentially $2.5 billion deal. This collaboration underscores AI's transformative potential in accelerating drug discovery and development processes. By leveraging artificial intelligence, Insilico aims to identify new drug candidates more efficiently, expediting their journey from bench to bedside. Kelun-Biotech is marking significant progress with its SAC-TMT program targeting non-small cell lung cancer (NSCLC), filling gaps left by Merck's phase 3 efforts. This development is crucial for providing more tailored therapeutic options in oncology, illustrating how advancements in drug development are driving forward personalized medicine. Roche continues its exploration of Alzheimer's disease treatments with a multifaceted approach that includes both amyloid and tau proteins as targets. While its phase 3 amyloid program is prominent, Roche's interest in tau protein highlights the complexity of tackling neurological disorders and the need for diverse therapeutic strategies. Meanwhile, Biogen remains steadfast in defending its anti-tau Alzheimer's candidate following mixed phase 2 results that showed slowed cognitive decline. Despite stock volatility, this endeavor illustrates the high-stakes nature of Alzheimer's research as companies pursue novel approaches to this challenging disease. Regulatory landscapes are also shifting as Johnson & Johnson halts development of an eye disease gene therapy after disappointing phase 2b results. This move reflects the inherent risks involved in gene therapy and underscores the necessity for thorough evaluation at each clinical stage. Medtronic's recall of its Harmony delivery catheter system due to potential detachment risks serves as a reminder of the paramount importance of safety and quality control in medical device manufacturing. Such recalls impact patient safety and emphasize regulatory vigilance over device reliability. In summary, these innovations demonstrate the dynamic nature of the pharma and biotech industries where cutting-edge science drives progress. Integrating AI into drug discovery, managing product lifecycles post-patent expiry, advancing personalized medicine, and maintaining regulatory diligence collectively shape a landscape focused on improving patient outcomes worldwide. Turning to recent scientific developments: Eli Lilly's presentation at AAIC 2026 on their anti-amyloid Alzheimer's drug Kisunla explores maintenance therapy possibilities once amyloid levels fall below a threshold. This potential shift could signify a paradigm change by extending therapeutic benefits and possibly improving long-term outcomes for patients with Alzheimer's. Biogen's advances with its anti-tau Alzheimer's therapy partnered with Ionis Pharmaceuticals further validate the tau hypothesis. The promising mid-stage data on their antisense drug Diranersen opens opportunities for other companies like Denali Therapeutics to explore similar avenues for treating neurodegenerative diseases. The industry is also witnessing a resurgence in biotech IPOs during 2026's first half, recovering from a sluggish 2025. This surge signals investor confidence in biotechnological innovation while providing capital for advancing research pipelines. Financial activities within the sector are robust as Attovia Therapeutics files for an IPO to fund its competitive pipeline against Sanofi's Dupixent. Meanwhile, Advancell's $315 million Series D funding supports advancing prostate cancer candidates into Phase 3 trials, backed by big pharma confidence in radiotherapy's potential. Lastly, regulatory transparency improves as the FDA resumes releasing drug rejection letters after a temporary pause—a move likely to influence future submissions significantly by offering clearer guidance on regulatory expectations. These developments collectively highlight how scientific innovation and strategic maneuvers transform pharmaceutical landscapes, promising profound impacts on patient care through advanced therapies and novel treatments worldwide. As these trends unfold, they reflect an industry increasingly reliant on technological integration and collaborations to drive future growth and innovation.Support the show

This event was part of the IfG's half-day conference, Regulation in a changing world: How to meet the needs of the future? Panellists discussed how the design of a regulatory system can best build investor confidence and encourage good long-term outcomes. Rt Hon George Eustice, former Secretary of State for Environment, Food and Rural Affairs (2020–22) Mark McAllister, Chair of Ofgem Stefanie Voelz, Senior Credit Officer at Moody's This session was chaired by Giles Wilkes, Senior Fellow at the Institute for Government. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Curious about a flexible, high-paying nonclinical career that still uses your medical expertise? In this episode, I'm joined by Dr. Keagen Hadley, an occupational therapist who built a successful career in regulatory medical writing without ever stepping into clinical practice. Dr. Hadley shares how he discovered this little-known field while working in clinical research, the persistence it took to break in, and why regulatory writing can be such an appealing option for physicians seeking flexibility, meaningful work, and strong earning potential. We also explore what regulatory writers actually do, who tends to thrive in this role, how AI is impacting the profession, and practical strategies for getting started. If you enjoy structure, attention to detail, and helping bring new therapies to patients, this conversation may open your eyes to an exciting career path you hadn't considered. In this episode we're talking about: What regulatory medical writing is and its role in drug, biologic, and device development The personality traits and skills that help people succeed in regulatory writing Dr. Keagen Hadley's unconventional path from occupational therapy to a thriving writing career How physicians can break into the field through networking, recruiters, and strategic positioning Compensation, flexibility, and career growth opportunities in regulatory writing How AI is influencing regulatory writing and why human expertise remains essential Resources, training recommendations, and practical advice for exploring this career path You can find the show notes for this episode and more information by clicking here: www.doctorscrossing.com/episode251 Links for this episode: The Clinician's Guide to Regulatory Writing | Keagen Hadley | Substack  Keagen Hadley | LinkedIn  Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by Wood and Foote 6 Month Road Map to Becoming a Regulatory Writer by Keagen Hadley Regulatory Medical Writing Masterclass  Medical Writing Resource Guide – This 11-page guide gives you an introduction to medical writing as well as links for courses, books, websites, and tips for exploring this diverse area. Includes steps you can take whether you want to do medical writing as a side gig, or work full-time as a freelancer or an employee. Land Your Dream Job With LinkedIn: 5 Steps To Get Started – Following these 5 tips will help you optimize your profile, connect and network with others, and have success applying to jobs on LinkedIn! Thank you for listening!

In this episode of Compliance Champions, Delphine Forma, Head of Policy Europe at Solidus Labs, speaks with Philipp Ringel, Team Lead for Regulatory Reporting at Bitpanda — one of Europe's largest and most licensed crypto platforms.They explore what regulatory reporting really involves at scale, including how Bitpanda manages over 100 reports across multiple licenses and regulatory frameworks. Philipp shares how the function has matured over five years, what makes crypto reporting uniquely complex compared to traditional finance, and how firms can design processes that hold up under scrutiny.The conversation goes deep on data — why quality and governance matter from day one, how to capture the right data points early in the customer journey, and how to normalise information across different reporting regimes. They also cover the role of automation and AI, the practical challenges posed by MiCA's still-evolving requirements, and how to navigate reporting to stablecoin issuers where centralised infrastructure simply doesn't exist yet.A practical, experience-led conversation for compliance and reporting professionals building the infrastructure that keeps regulated crypto firms accountable.

The award-winning Compliance into the Weeds is the only weekly podcast that takes a deep dive into a compliance-related topic, literally going into the weeds to explore it in greater depth. Looking for some hard-hitting insights on compliance? Look no further than Compliance into the Weeds! In this episode of Compliance into the Weeds, Tom Fox and Matt Kelly discuss the June 29 Supreme Court decision in Trump v. Slaughter. This decision upheld the president's power to fire independent agency commissioners at will (with a carve-out for the Federal Reserve), overturning long-standing protections from Humphrey's Executor. Kelly argues the ruling will politicize and degrade regulatory agencies, deter qualified minority-party commissioners, increase rulemaking volatility, and shift power away from Congress toward courts as rules are challenged. As an example, they cite the SEC's proposal to allow semi-annual rather than quarterly reporting, which drew about 80,000 comments, with roughly 99% opposed, yet they predict it may proceed and later be reversed, creating compliance burdens. They then cover Georgia author Jean Wilson, sentenced to 10 years for a $66 million Medicare fraud scheme while writing healthcare compliance books. Key highlights: The Slaughter Ruling Regulatory Volatility Ahead Who Will Serve as Commissioners Fed Carve-out and Court Power Compliance Impact and No Easy Answers Healthcare Compliance Fraud Story (Or is it from The Onion?)  Resources: Matt in Radical Compliance  Tom Instagram Facebook YouTube Twitter LinkedIn A multi-award-winning podcast, Compliance into the Weeds was most recently honored as one of the Top 25 Regulatory Compliance Podcasts, a Top 10 Business Law Podcast, and a Top 12 Risk Management Podcast. Compliance into the Weeds has been conferred the Davey, Communicator, and W3 Awards, all for podcast excellence. Learn more about your ad choices. Visit megaphone.fm/adchoices

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into an array of groundbreaking advancements and strategic movements reshaping the landscape of healthcare and medicine. Recent strides in Alzheimer's research have highlighted Biogen's promising Phase 2 clinical trial results for diranersen, an antisense oligonucleotide targeting the tau protein. Unlike traditional amyloid-targeting therapies, this approach offers a novel mechanism that could diversify treatment options for Alzheimer's patients. By addressing tau pathology, a critical feature of Alzheimer's disease, Biogen's findings may influence research trajectories and potentially lead to improved patient outcomes. In tandem with this, Biogen and Eisai have received FDA approval for a subcutaneous formulation of Leqembi (lecanemab), targeting amyloid-beta plaques. This new delivery method is poised to enhance patient compliance and accessibility, marking significant progress in broadening Alzheimer's treatment modalities. In oncology, AstraZeneca has entered into a substantial $1.5 billion licensing agreement with Dizal Pharmaceutical for lung cancer therapies. This strategic partnership emphasizes the importance of collaborative efforts in advancing cancer treatment and highlights the role of targeted therapies in addressing unmet medical needs. Additionally, Merck KGaA's Erbitux has secured European Commission approval for first-line treatment of BRAF V600E-mutant metastatic colorectal cancer. By focusing on specific genetic mutations, this approval illustrates the shift towards precision medicine, where treatments are tailored based on individual genetic profiles. The industry is also embracing advanced technologies such as artificial intelligence (AI) to enhance drug discovery processes. Chai Discovery's partnership with Novartis exemplifies this trend, as they focus on AI-driven therapeutic antibody discovery. Meanwhile, Ardigen and Veraxa Biotech's collaboration in optimizing T-cell engager and ADC drug discovery demonstrates AI's growing role in reducing timeframes and costs associated with bringing new therapies to market. Regulatory updates from the FDA seek to streamline registration rules to alleviate manufacturing burdens for biopharma companies, reflecting ongoing efforts to improve operational efficiencies in drug production. Additionally, new guidance on psychedelics indicates a regulatory openness that could stimulate innovation within neurological therapeutics. In other news, HUYABIO's Phase 3 trial results have shown promise for advanced skin cancer patients through a combination therapy involving Bristol Myers Squibb's Opdivo. This success underscores the potential of combination therapies to enhance treatment efficacy. Meanwhile, cell therapy is experiencing a transformative shift with Cellares' advancements in automating manufacturing processes. These innovations promise broader access to life-saving cell therapies by accelerating production timelines and reducing costs. Turning to business developments, Spero Therapeutics' $1.1 billion deal with Innovent Biologics marks a strategic pivot towards immune modulation therapies, highlighting the growing interest in autoimmune diseases. Concurrently, Avere Therapeutics' public listing via a reverse merger with NextCure and acquisition of an IL-23 drug signifies ongoing consolidation within the sector. On the regulatory front, Beckman Coulter's expansion of its Alzheimer's diagnostic portfolio through a CE mark for its p-tau217 assay enhances diagnostic capabilities crucial for early detection and management amid an aging global population. As we look globally, cities like Basel and Beijing are emerging as biotech hubs, attracting top talent and investments while fostering innovation. Amid these shifts, industry professionals are encouraged to adapt to evolving technological landscapes, particularly with AI poised to enhance decision-making processes and streamline clinical workflows. These developments illustrate a dynamic phase for pharma and biotech sectors where scientific breakthroughs are closely intertwined with strategic business decisions and regulatory advancements. As we continue to navigate these changes, the potential for delivering more effective treatments across various therapeutic areas is immense. Stay tuned as we bring you more insights into how these innovations are shaping the future of healthcare globally. Thank you for joining us at Pharma Daily; until next time.Support the show

In this episode of Curing with Sound, we speak with Matt Myers, PhD, a research physicist and founder of Puente Translational Sciences. Dr. Myers spent more than 30 years at the U.S. Food and Drug Administration (FDA), where he helped develop tools to evaluate emerging devices and applications, including focused ultrasound. Drawing on decades of experience, Dr. Myers offers an insider's perspective on the FDA's role in advancing medical innovation and explains how researchers and device developers can work more effectively with regulators to accelerate patient access to new therapies. He discusses his early involvement with the first focused ultrasound submission for uterine fibroids, his important work during the COVID-19 pandemic, and his current efforts to help researchers and manufacturers accelerate the path to market for therapeutic ultrasound devices. Discussion highlights: Working with the FDA: How the FDA collaborates with researchers and manufacturers to improve devices, streamline regulatory pathways, and help bring safe and effective technologies to patients. The Evolving Field of Neuromodulation: Why focused ultrasound neuromodulation is generating growing regulatory interest, and how standardized reporting will strengthen future research and clinical translation. Preparing the Next Generation: Dr. Myers' advice for early-career researchers on developing the technical skills and interdisciplinary expertise needed to succeed in the rapidly evolving field of therapeutic ultrasound. EPISODE TRANSCRIPT ---------------------------- QUESTIONS? Email podcast@fusfoundation.org if you have a question or comment about the show, or if you would you like to connect about future guest appearances.  Email info@fusfoundation.org if you have questions about focused ultrasound or the Foundation.  FUSF SOCIAL MEDIA LinkedIn X Facebook Instagram TikTok YouTube FUSF WEBSITE https://www.fusfoundation.org FOCUSED ULTRASOUND TREATMENT SITES https://www.fusfoundation.org/the-technology/treatment-sites/ SIGN UP FOR OUR FREE NEWSLETTER https://www.fusfoundation.org/newsletter-signup/ READ THE LATEST NEWSLETTER https://www.fusfoundation.org/the-foundation/news-media/newsletter/ DOWNLOAD "THE TUMOR" BY JOHN GRISHAM (FREE E-BOOK) https://www.fusfoundation.org/read-the-tumor-by-john-grisham/

What happens when the brightest minds in legal, technology, and innovation come together to shape the future of our profession? Welcome to the Legally Speaking Podcast Legal Tech Talk 2026 miniseries. As the UK's number one legal podcast and show ranked in the top 1% of podcasts globally, we're delighted to be returning as the official media partner for Legal Tech Talk for the third time. Having supported this event since the beginning. We've witnessed firsthand how it has become Europe's largest legal technology conference, bringing together the people, ideas, and innovations transforming the legal industry. Across this special series, we'll be speaking with some of the world's leading legal professionals, founders, technologists, change makers to explore what's next for law. Because our mission remains the same. Inspiring legal minds, transforming legal futures. Let's get into it. Jeffrey Shapiro is a legal tech and future-of-law thinker who talks about how AI is changing the legal industry, but not just as a tool problem — more as a mindset, culture, and integration challenge. He focuses on breaking down silos so firms can use data intelligently, staying ahead of regulation like the EU AI Act, and keeping human trust and authenticity central as technology advances. He also emphasises curiosity, continuous learning, and community as key traits for future legal leaders, often explaining complex ideas in memorable, down-to-earth ways. So why should you be listening in? You can hear Rob and Jeffrey discussing:- Cross-silo data integration matters- Human connection builds trust- Regulatory agility is critical- Curiosity shapes future leadership- Openness improves collaboration.Connect with Jeffrey Shapiro here - https://www.linkedin.com/in/jtshap/

The secondary review: Corrective Backup? Or a layer of quality assurance?Given that clinical documentation integrity (CDI) invariably has interpretative variability, a secondary review is intended to bring consistency to complex issues, according to the Talk Ten Tuesday special guest, Mary McGrady, vice president of CDI for Accuity Health. During the next live edition of the popular Internet broadcast, Mary McGrady will clear up the misunderstanding of the secondary review.Other well-known subject-matter experts will also join the broadcast with more news to report, including the following:• SDoH Report: Tiffany Ferguson will report on news happening at the intersection of compliance and medical record coding.• The Coding Report: Christine Geiger returns to Talk Ten Tuesdays to report on the latest coding news.• POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of California-Davis Medical Center, will share her point of view during the broadcast.

John Robinson, VP, strategy, and Abigail Caldwell, SVP and health actuary, Amwins Benefits, discuss how insurers and employers are adapting to rising benefit costs and an evolving employee benefits risk landscape.

(3) The Phony War and Strategic Reserves: Regulatory Displacement, the Iran-US "Phony War," and the Doctrine of Unconditional Surrender Guests in Londinium, 92 AD: Gaius and Germanicus. Broadcasting a "bootleg edition" from a parking lot after being forced out by the building inspector, the hosts discuss the unsustainable nature of the escalating US-Iran conflict. Gaius compares the current "drip drip" of hostilities to the minor-sounding reports from 1938–1939, questioning the sustainability of these incremental escalations. Germanicus frames the conflict as a "Sitzkrieg" or "phony war," noting that unlike 1940, the current pressure is the depletion of strategic oil reserves — the crisis isn't "instantly imminent," but the drawdown makes it temporary. He critiques the American "neuralgia" of demanding unconditional surrender, an unattainable goal he traces from the Civil War to modern leaders like Trump and Biden, arguing that a military tradition requiring demonized enemies and total submission prevents realistic resolutions. They conclude that the current diplomatic and military path is a "will-o'-the-wisp" that cannot be achieved through air power or Blitzkrieg. (3)1945 BBERLIN

(1) Regulatory Certitude in Londinium: The Power of the Building Inspector and Beachfront Evictions Guests in Londinium, 92 AD: Gaius and Germanicus. The show is temporarily halted due to occupancy issues at the wine bar. Gaius admits to a "completely unforgivable error": failing to give the building inspector an annual birthday raise. He notes that even far from Rome, the local inspector's "red ticket" carries enough weight to shut down their beachfront wine bar despite the Emperor Domitian's distance. The inspector cited concerns about running water, windows, and roof tiles, though Gaius suspects it was a move for more "generous gifts." He laments that his focus on a "robot" sent from Chinafor the orchestra caused him to neglect the inspector's welfare. The hosts plan a "great big party" with the help of centurions to scrub the facility and restore order for the following week's broadcast. (1)londinium 1682 ad

Payer-driven clinical validation is a common reason given by payers to remove ICD-10-CM/PCS diagnosis and procedure codes affecting reimbursement or quality-based payment models (e.g., the Centers for Medicare & Medicaid Services/CMS Hospital-Acquired Conditions), even though these codes are based on the documentation of licensed providers.During the next Internet broadcast of the venerable Monitor Monday, Dr. James S. Kennedy of CDIMD will propose a strategy that engages payers in how patient conditions or treatments should be defined, diagnosed, and documented, elevating the practice of medicine and confronting denials that are often based on misinterpretations of current clinical literature.Broadcast segments will also include these instantly recognizable features:• Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.• The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.• Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.• Legislative Update: Cate Brantley, legislative affairs liaison for Zelis, will report on current healthcare legislation.

For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well.Few or no findings.Positive feedback from auditors.Management celebrates.But does passing an audit really mean your QMS is healthy?In this episode of the Medical Device Made Easy Podcast, we explore why the answer is often no.Audits Are Samples—Not Complete EvaluationsWhether it's an ISO 13485 audit, a Notified Body assessment, an FDA inspection, or an internal audit, auditors can only review a small sample of your quality system.They cannot examine every complaint, every supplier, every design decision, or every production batch.A successful audit demonstrates compliance with the sampled evidence—but it does not guarantee that every aspect of the system is functioning effectively.The "Audit Mode" ProblemMany organizations unintentionally enter "Audit Mode" before inspections.Training records are updated.CAPAs are closed.Procedures are revised.Management reviews suddenly take place.While preparation is important, organizations should ask themselves:Are we improving our QMS—or simply preparing for an audit?Culture Matters More Than FindingsSome of the most significant quality risks rarely appear during an audit.Examples include:Employees afraid to report mistakesPoor communication between departmentsWeak supplier relationshipsDesign decisions that are never challengedInformal workarounds that bypass documented proceduresThese issues can remain invisible during a short audit while gradually increasing organizational risk.Measuring the Real Health of Your QMSInstead of focusing only on audit findings, management should monitor indicators such as:Complaint investigation timelinesCAPA closure performanceSupplier management effectivenessRisk management updatesCross-functional communicationNear-miss reportingContinuous improvement initiativesThese metrics often provide a far more accurate picture of QMS maturity than the number of audit findings alone.Final ThoughtPassing an audit is an important achievement and deserves recognition.However, organizations should never confuse regulatory compliance with operational excellence.A healthy Quality Management System is not built to impress auditors.It is built to consistently deliver safe, effective, and compliant medical devices while continuously improving every day—even when no auditor is watching.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Charles Schwab's Adam Lynch argues that Bitcoin's recent rally is more of a relief bounce driven by softer jobs data and easing macro fears than a lasting trend reversal. He discusses Michael Saylor's latest Bitcoin sale, the challenges facing U.S. crypto legislation, and why Hyperliquid's HYPE token has emerged as one of the sector's standout success stories.======== Schwab Network ========Empowering every investor and trader, every market day.Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about

Aside from a handful of high-profile deals, merger and acquisition activity in the US oil and gas sector has been tepid in recent months even as war in the Middle East pushed oil prices to multi-year highs. In this episode, S&P Global Energy's Christopher van Moessner, editor, oil futures, is joined by Americas news editor Ashok Dutta and senior reporter Eamonn Brennan to discuss the outlook for M&A activity in the sector and how it has been impacted by a White House that from the start has positioned itself as pro-oil. They dig into how the administration's deregulation efforts have so far failed to manifest in a wave of oil and gas dealmaking that has been seen in other industries, and how capex discipline and general price uncertainty have presented headwinds to M&A activity in the sector. 

Recorded live at the Retail Collective Summit, this dynamic panel features top state legislators, federal economic advocates, former regulatory chiefs, and prominent venture capital moderators addressing the macro-economic realities of scaling private enterprises. The discussion dives deep into the shifting landscape of corporate funding, uncovering how single-family offices are increasingly acting as direct institutional investors to bypass traditional venture capital bottlenecks. Speakers outline the critical need to transition funding models from traditional enterprise software toward advanced manufacturing and hard technology, shortening volatile supply chains to build a more durable, locally resilient infrastructure. The conversation also tackles the complex tensions between localized regulatory sandbox programs and the massive paperwork burdens imposed by federal agencies on small business operators. Looking firmly 20 to 30 years into the future, the panelists confront the hot-button issue of energy grid infrastructure and mega data center development. They map out the precise policy frameworks required to manage critical minerals and advanced technological disruptions without exhausting local energy or water supplies. It is an essential masterclass on maintaining an elite economic outlook while scaling capital, culture, and community on a global stage.  

What does institutional crypto adoption actually look like beyond the headlines?Harriet Browning, Global VP of Sales at Twinstake, joins Bitcoin.com's Alex Richardson at Proof of Talk 2026 in Paris to discuss how institutional staking is evolving and why infrastructure, not speculation, is becoming the focus of the next phase of crypto adoption.Drawing on her background in TradFi derivatives, Browning explains why staking should be viewed as core blockchain infrastructure, how non-custodial institutional staking works, and what large investors expect from validators today.Topics include:- Why institutional staking is gaining momentum- The shift from TradFi to DeFi- How non-custodial staking works- Validator performance and Solana staking- Regulatory momentum and institutional requirements- The role of the Proof of Stake Alliance- Why compliance, custody, reporting, and infrastructure matter more than everRecorded at Proof of Talk 2026 in Paris.

Regulatory compliance is shifting from periodic manual reviews to continuous, automated monitoring — driven by rising case volumes, stricter expectations, and the gaps that point-in-time checks leave open. Here is how the model is changing. To learn more, visit https://caibots.com/ CAIBots City: Plainsboro Township Address: 35 Knox Ct Website: https://caibots.com/

What happens when the Inpatient-Only (IPO) List goes away?The entire list is expected to be eliminated Jan. 1, 2028.This will necessitate careful, patient-specific status determinations, rather than automatic assumptions based only on the procedure being performed.The removal of a procedure from the IPO list does not mean that every such procedure must be classified as “outpatient.” Instead, the clinical team must evaluate the individual patient's medical condition, functional needs, home situation, and anticipated post-operative course.Listen and learn during the next upcoming edition of Talk Ten Tuesdays, when Dr. Juliet Ugarte Hopkins will offer practical patient function concepts for supporting inpatient status in the absence of the IPO list.Other well-known subject-matter experts will also join the broadcast with more news to report, including the following:• CDI Report: Cheryl Ericson will provide an update on all things clinical documentation integrity (CDI).• SDoH Report: Tiffany Ferguson will report on news happening at the intersection of compliance and medical record coding.• The Coding Report: Christine Geiger returns to Talk Ten Tuesdays to report on the latest coding news.• POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of California-Davis Medical Center, will share her point of view during the broadcast.

Clinical trial support companies are rapidly adopting AI, but sponsors have been more hesitant. Raj Indupuri, CEO of eClinical Solutions, gives the top three reasons behind the holdup in AI agent deployment. He explains the specific pattern of uptake for these agents, the required human-in-the-loop oversight, and how the agents can improve clinical trial velocity. Host Deborah Borfitz also gives the latest news on a highly acclaimed treatment for pancreatic cancer, filling evidence gaps in drug safety during pregnancy, guidelines for routinely collected health data for research purposes, an innovative portal aiding bidirectional communication with patients, and more. Show Notes News Roundup KRAS inhibitor therapy for pancreatic cancer Study in The New England Journal of Medicine  News on the Fred Hutch Cancer Center website  Target trial emulation in rural areas Perspective in the Medical Journal of Australia News on the Griffith University website   AI for improving drug safety during pregnancy Report from the Journal of Medical Internet Research Guidelines on the use of routinely collected data Article in The BMJ New regulatory framework in the U.K. Press release by the Medicines and Healthcare products Regulatory Agency  Participant Engagement Portal Article in JNCI Cancer Spectrum Press release from the Alliance for Clinical Trials in Oncology The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.  

In this episode of Medsider Radio, we sat down with Dr. Sudhir Srivastava, founder, chairman, and CEO of SS Innovations (Nasdaq: SSII). The company's SSi Mantra surgical robotic system supports a variety of surgical robotic procedures, including cardiac surgery. Sudhir brings more than three decades of experience in minimally invasive and robotic cardiac interventions, having served as Director of Robotic Cardiac Surgery at the University of Chicago and founder of the International College of Robotic Surgery. A pioneer in the field, Sudhir has performed more than 1,400 robotic procedures, including over 750 beating-heart totally endoscopic coronary artery bypass (TECAB) surgeries.In this interview, Sudhir discusses what it takes to democratize robotic surgery beyond affordability, how SS Innovations built teleproctoring, telesurgery, and the supporting infrastructure for its robotic platform, and his milestone-based approach to financing a capital-intensive medtech company. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Sudhir Srivastava, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:01) - Sudhir's journey from performing the world's first beating-heart robotic bypass to founding SS Innovations (07:14) - The 22-year-old patient who became the catalyst for Sudhir's affordable robotic surgery platform (08:59) - Building Mantra 3 from the ground up in just five months (12:14) - Inside the engineering process that eliminated months of costly iteration (16:20) - The question that shaped SS Innovations: "How do you democratize access?" (27:10) - From one office to performing 24 telesurgeries in 12 hours across India (29:29) - How a mobile training bus became part of Sudhir's answer to make robotic surgery accessible (33:49) - Lessons from commercializing a surgical robotics platform across developing markets (39:43) - Starting with just $5 million: Sudhir's milestone-based approach to fundraising

Behavioral health services continue to face heightened payer scrutiny. The result: inaccurate documentation, coding, and compliance issues.Panacea Healthcare recently hosted a webinar that focused on three high-risk areas: relative to Behavioral Health–telehealth, psychotherapy with evaluation and management (E&M) services, and the Collaborative Care Model (CoCM).Special guest George Kelly is expected to summarize these issues while outlining the common compliance pitfalls, documentation requirements, coding best practices, and audit risks associated with each service.Broadcast segments will also include these instantly recognizable features:• Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.• The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.• Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.• Legislative Update: Adam Brenman, legislative affairs analyst for Zelis, will report on current healthcare legislation.

This week on Autonomy Markets, Grayson Brulte and Walter Piecyk discuss the end of Waymo and Uber's partnership in Phoenix, Tesla's Cybercab hitting the streets of Austin branded for America 250 and Waymo's "Because they're everything" World Cup campaign.As Tesla gets closer and closer to putting the Cybercab into service, the U.S. Government is inching toward a national framework that would allow vehicles with no steering wheel and no pedals to deploy across all 50 states and charge for rides.It is the regulatory environment that we believe Tesla is waiting to change before deploying Cybercab into the fleet, even if the rides are free. As Tesla waits for regulatory certainty, The Road to Autonomy broke the news that Waymo and Uber quietly ended their Phoenix partnership, noticing an update on the Uber autonomous vehicle site.The Phoenix partnership, which lasted 948 days, consisted of a fleet of 12 vehicles that serviced a 180 square mile area. Important to note that this was a dedicated fleet for Uber and the vehicles were not part of the traditional Waymo fleet.Now that Waymo and Uber have divorced in Phoenix, we believe it is only a matter of time until they divorce in Austin, where the service has been live for 482 days, and Atlanta, where the service has been live for 370 days. Both partnerships could unwind by the first quarter of 2027.On the Foreign Autonomy Desk, Grayson and Walt discuss the global growth of FSD and Volkswagen and Bosch ending their automated driving partnership, the latest in a long line of stalled autonomy efforts at the German automaker.Episode Chapters00:00 Happy 250th Birthday, America1:15 Waymo and Uber Phoenix Divorce5:47 Dara, Nuro and Wayve Signals8:24 Who Could Backfill Phoenix for Uber?13:52 The Fizzling Demand Narrative17:51 Cybercab, Branded for America 25021:53 Regulatory, Not Safety, Is Holding Cybercab Back24:50 Tesla Semi25:54 Waymo's World Cup Because They're Everything Campaign28:06 Robotaxis at Airports29:32 Chinese Made Vehicles31:11 Foreign Autonomy Desk34:15 Next WeekFollow The Road to Autonomy Indices--------About The Road to AutonomyThe Road to Autonomy is the leading applied intelligence platform covering the convergence of automation, autonomy, and the Autonomy Economy.™.Through our podcasts, newsletter, and proprietary applied intelligence, we set the narrative for institutional investors, industry executives, and policymakers navigating the convergence of automation, autonomy, and economic growth.Join institutional investors and industry leaders who read This Week in The Autonomy Economy every Sunday. Each edition delivers exclusive insight and commentary on the autonomy economy, helping you stay ahead of what's next.Sign up for This Week in The Autonomy Economy newsletterSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

The dominant structural mechanism explored in this episode centers on governance gaps in access management and the resulting liability transfer to MSPs. The discussion highlights how fragmented identity stacks, unmanaged access, and reliance on manual tracking expose MSPs to growing contractual, operational, and legal risk. Companies and technologies referenced include Microsoft 365, Google Workspace, Okta, ConnectWise, and specific access governance solutions targeting the channel. The ConnectWise 2026 Threat Report identifies credential abuse as a core attack vector, underscoring how unaddressed authorization and access drift remain a structural exposure area. The episode cites multiple indicators and supporting data. According to the ConnectWise 2026 Threat Report, credential abuse is now the primary attack vector, with attackers commonly exploiting active and orphaned accounts left unmanaged in client environments. Fragmented identity stacks complicate the onboarding and offboarding process, with onboarding often requiring 45 minutes per client as technicians navigate numerous access portals. The prevalence of shadow IT, orphaned accounts, and missed deprovisioning windows was discussed as persistent drivers of both operational overhead and increased incident risk. Supporting developments include community-documented scenarios where multi-factor authentication (MFA) was present but insufficient to prevent breaches, particularly when privilege escalation or temporary exclusions remain unaddressed. Examples such as the Reddit phishing event and Microsoft's handling of MFA via VOIP demonstrate how authentication is distinct from governance, and that temporary access or exceptions frequently become permanent, heightening exposure. Regulatory environments—including healthcare, finance, and government—were cited as adding further requirements for explicit governance controls and auditable access policies, while manual spreadsheet tracking often fails to meet these demands. The operational implications for MSPs include the need to move beyond basic practice such as MFA and endpoint protection, toward purpose-built tools and processes that provide continual visibility, auditable controls, and policy enforcement for client access. Without this, MSPs face increased administrative burden, billing discrepancies, contractual liability, and reputational risk. As regulatory audits become more demanding and clients demand clearer evidence of governance, service providers must reconcile the tradeoffs between increased process complexity and the need for automated, enforceable identity governance. This shift challenges existing pricing models, requiring MSPs to justify and potentially repackage their service offerings in the context of risk management and operational maturity.

Send us Fan MailAI is transforming healthcare. Medicare policy is evolving. Regulatory scrutiny is intensifying. What do these changes mean for healthcare leaders, hospice executives, nonprofit organizations, and healthcare professionals?In Part Two of this quarterly healthcare leadership update, Chris Comeaux and Cordt Kassner examine the biggest healthcare trends of 2026, exploring how artificial intelligence in healthcare, Medicare policy, healthcare affordability, hospice fraud enforcement, regulatory compliance, and healthcare innovation are reshaping hospice and the broader healthcare industry. They discuss how AI is changing the healthcare workforce, why quality and transparency matter more than ever, and what healthcare executives should know about the future of hospice care, palliative care, and value-based healthcare.Whether you lead a hospice organization, health system, nonprofit healthcare organization, or healthcare business, this episode provides practical leadership insights to help you navigate healthcare policy changes, prepare for emerging technology, understand the future of Medicare, and make strategic decisions in an increasingly complex healthcare environment. If you're interested in healthcare leadership, AI in hospice, healthcare management, Medicare reform, or the future of healthcare, this conversation will help you anticipate what's next instead of simply reacting to today's headlines.Episode Highlights✔ AI: Augmenting people vs. replacing jobs✔ Medicare policy and healthcare affordability✔ Hospice fraud enforcement & regulatory trends✔ Industry consolidation & nonprofit outlook✔ Leadership strategies for navigating changeChapters00:00 Introduction01:05 Looking Back at Q2 202606:05 The Biggest Healthcare Trends07:11 Reinvigorating Hospice Quality12:09 AI, Jobs & the Future of Healthcare19:35 Healthcare Affordability & Medicare25:27 Hospice Market Growth27:18 Industry Consolidation & Provider Rankings34:02 Closing Thoughts

AI is transforming healthcare. Medicare policy is evolving. Regulatory scrutiny is intensifying. What do these changes mean for healthcare leaders, hospice executives, nonprofit organizations, and healthcare professionals?In Part Two of this quarterly healthcare leadership update, Chris Comeaux and Cordt Kassner examine the biggest healthcare trends of 2026, exploring how artificial intelligence in healthcare, Medicare policy, healthcare affordability, hospice fraud enforcement, regulatory compliance, and healthcare innovation are reshaping hospice and the broader healthcare industry. They discuss how AI is changing the healthcare workforce, why quality and transparency matter more than ever, and what healthcare executives should know about the future of hospice care, palliative care, and value-based healthcare.Whether you lead a hospice organization, health system, nonprofit healthcare organization, or healthcare business, this episode provides practical leadership insights to help you navigate healthcare policy changes, prepare for emerging technology, understand the future of Medicare, and make strategic decisions in an increasingly complex healthcare environment. If you're interested in healthcare leadership, AI in hospice, healthcare management, Medicare reform, or the future of healthcare, this conversation will help you anticipate what's next instead of simply reacting to today's headlines.Episode Highlights✔ AI: Augmenting people vs. replacing jobs✔ Medicare policy and healthcare affordability✔ Hospice fraud enforcement & regulatory trends✔ Industry consolidation & nonprofit outlook✔ Leadership strategies for navigating change

SponsorMedboard: https://www.medboard.com/EuropeWell-Established Technologies - Publication of the Delegated act: https://ec.europa.eu/newsroom/sante/newsletter-archives/770132 Delegated acts:Class III and implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451Class Iib implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359In line with the Administrative Simplification Agenda COMBINE Phase 2 - Increase of Scope : https://ec.europa.eu/newsroom/sante/newsletter-archives/76937Incease of Scope:Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with:Performance studies of IVDs or companion diagnostics requiring authorisationClinical investigations of medical devices requiring authorisation Combined studies with Advanced Therapy Medicinal Products (ATMPs) possibleOptions for single or separate sponsorsProcedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2Exploration of single protocols and joint documents  Austria: FSC deficiencies - Most issues identified: https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale/common-deficienciesSSCP, Upload you should! - MDCG 2026-4 released: https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdfStart Date October 2026, Due date February 2027 Harmonized Standard update - A full list was disclosed: https://eur-lex.europa.eu/eli/dec_impl/2026/1231/ojMDCG 2021-5 Rev 1 EU REP Symbol -Should you continue to use EC REP?   https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdfDuring the transition time, within a staggered approach for the implementation, it is acceptable to use one or both symbols ‘EC REP' and ‘EU REP' on different levels of packaging, as well  Team-NB- Micro Small Entreprise - Discount imposed  https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdfUKUpdate of UK Borderline Guide - Remove of antimicrobial substances as Medical Devices: https://www.gov.uk/government/publications/borderlines-with-medical-devicesThe line: 'Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.' has been changed to this: Alcohol-only pre-injection swabs and wipes are considered to be medical devices.SwitzerlandSwissdamed: RegistrationNew option: M2M and Master UDI-DI: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/neu-online-editor-m2m-produktregistierung-master-udi.htmlSwissdamed UDI User guide: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_841e_hb_swissdamed_user_guide_udi_devices_module.pdf.download.pdf/BW630_40_841e_HB_swissdamed_User_Guide_UDI_Devices_Module.pdfMedtech Conf: Medtechconf.comPodcastEpisode 393 - Best of „AI CE marking“: https://podcast.easymedicaldevice.com/393-2/Episode 394 - NC vs CAPA: Are You Opening the Wrong Records?: https://podcast.easymedicaldevice.com/394-2/Episode 395 - “We've Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices: https://podcast.easymedicaldevice.com/395-2/Easy Medical DeviceConsulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/BOSS Program: Back Office ServiceseQMS: https://easymedicaldevice.com/smarteye-eqms/EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/Authorized Representative in EU, UK and SwitzerlandMarket access all over the world: https://easymedicaldevice.com/services/market-access/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a wave of exciting advancements and strategic movements shaping the landscape of this ever-evolving industry. Starting with a significant breakthrough in cell therapy, the FDA has granted approval to Orca Bio's Tregzi, a novel treatment aimed at preventing graft-versus-host disease (GVHD) in blood cancer patients undergoing allogeneic transplants. This approval emphasizes the potential of regulatory T cells in mitigating the severe complications that often accompany such transplants. The success of Tregzi not only marks a pivotal moment for cell therapy but also heralds a new era in transplant medicine where cellular therapies can significantly improve patient outcomes by reducing GVHD incidence. In other strategic moves, Ipsen's acquisition of Memo Therapeutics for up to $796 million highlights the industry's focus on addressing unmet needs in transplant medicine. Memo's work on monoclonal antibodies targeting the BK virus—a significant threat to kidney transplant patients—reflects a growing trend towards personalized medicine and targeted biologics. This acquisition is poised to bring much-needed therapeutic interventions to market, underscoring the sector's commitment to innovative solutions. Meanwhile, Anthropic is making waves with the introduction of Claude Science AI Workbench, accompanied by an internal drug discovery program aimed at neglected diseases. This initiative underscores the transformative role of artificial intelligence in drug discovery, particularly in areas previously overlooked due to limited commercial incentives. By accelerating the identification and development of novel therapeutics, AI-driven platforms promise breakthroughs in treating rare and neglected diseases. In clinical trial news, Abivax has reported promising Phase 3 safety data for obefazimod, a miR-124 enhancer targeting ulcerative colitis. By alleviating previous cancer-related concerns, obefazimod stands out as a potential small molecule oral therapy for autoimmune conditions. This advancement demonstrates ongoing innovation in small molecule therapeutics designed to modulate immune responses, expanding treatment options for ulcerative colitis patients. On the financial front, several companies are bolstering their pipelines through significant funding efforts. Alvotech has secured a $75 million term loan to enhance its biosimilar pipeline, reflecting the increasing importance of cost-effective biologic alternatives. AB Science has raised approximately $2.62 million focusing on oncology and rare diseases like acute myeloid leukemia (AML) and amyotrophic lateral sclerosis (ALS). Additionally, Flare Therapeutics' $85 million Series C round emphasizes precision medicine approaches targeting transcription factors, illustrating the industry's dedication to precision medicine. Regulatory landscapes are also shifting with Sarepta Therapeutics' FDA acceptance for full approval bids on Amondys 45 and Vyondys 53 despite confirmatory trial challenges. These therapies leverage exon skipping technology for Duchenne muscular dystrophy treatment, highlighting the intricate balance between accelerated approvals and robust clinical evidence requirements. In mergers and acquisitions news, Kimball Electronics' acquisition of Helvoet Polymer Technologies expands their drug delivery systems capabilities across Europe and India. This strategic alignment reflects broader industry trends towards integrated service offerings and global expansion efforts. Regulatory challenges continue with leadership changes at the FDA as Vijay Kumar steps down amid ongoing turbulence within gene and cell therapy sectors. Additionally, Angitia Biopharmaceuticals' termination of its Phase 3 trial for its BMP-6 candidate illustrates inherent risks and strategic pivots often necessary in drug development. Turning our focus globally, China's approval of its first CAR-T therapy for solid tumors signals a pivotal moment in oncology. This milestone could spur similar advancements worldwide, particularly drawing interest on when such treatments might receive approval in other regions like the United States. Moderna's expansion into in vivo CAR-T therapies for autoimmune diseases further marks a strategic divergence from traditional approaches, aiming to create off-the-shelf solutions that redefine treatment paradigms. Gene therapy continues to gain traction as Uniqure navigates regulatory reversals from the FDA regarding its Huntington's disease gene therapy filing for accelerated approval. This development hints at a broader shift within regulatory bodies towards fostering innovation in rare disease treatments under new leadership directives. Industry-wide trends also reveal a notable shift towards automation in cell therapy production led by companies like Cellares and Ori. This reflects growing demands for scalable manufacturing processes that enhance production capabilities while reducing costs. Overall, these developments illustrate a dynamic landscape where scientific innovations, strategic partnerships, regulatory adjustments, and technological integrations drive progress across various medical fields. As these sectors evolve, they hold vast potential for transforming patient care through groundbreaking therapeutic options and improved healthcare delivery systems worldwide.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant advancements and strategic shifts reshaping the industry landscape. To begin, the U.S. Food and Drug Administration has taken a noteworthy step by selecting key industry players, including Eli Lilly, Regeneron, Fujifilm, and Kriya Therapeutics, for its PreCheck pilot program. This initiative is designed to enhance U.S. drug manufacturing capabilities, emphasizing the importance of robust domestic production. By reducing dependency on international supply chains, the program aims to expedite the delivery of critical therapies, highlighting a strategic move towards self-reliance in pharmaceutical manufacturing. In oncology news, Beone's Brukinsa (zanubrutinib), a small molecule BTK inhibitor, has demonstrated a remarkable 43% reduction in risk of progression for patients with first-line mantle cell lymphoma in its Phase 3 trial. This breakthrough offers a promising chemotherapy-free option for non-Hodgkin lymphoma treatment, marking significant progress in targeted cancer therapies that could improve patient outcomes in previously underserved areas. Meanwhile, Boulevard Bio and Metis TechBio have sealed a substantial licensing agreement valued at $1.6 billion for MTS-128, a trispecific T-cell engager aimed at autoimmune diseases. This collaboration reflects a broader industry trend towards leveraging advanced AI and machine learning technologies to enhance the development of precision medicine and personalized therapies. Such partnerships indicate a shift towards more innovative approaches to tackling complex disease mechanisms and illustrate burgeoning interest in multispecific biologics within immunotherapy domains—offering new avenues for targeting multiple disease pathways simultaneously. On the regulatory front, Sanofi is advancing efforts to expand the U.S. label for Nexviazyme (avalglucosidase alfa) following successful Phase 3 trials for infantile-onset Pompe disease. As an enzyme replacement therapy targeting GAA enzyme deficiency, Nexviazyme could address a critical gap in treatment options for this debilitating genetic disorder, underlining the importance of regulatory pathways in facilitating access to life-saving therapies. Financially, Beeline Medicines has garnered $126.3 million in Series A extension funding to propel its autoimmune programs originally sourced from Bristol Myers Squibb. Similarly, SmartBax has raised €6.3 million to advance its lead antibiotic program targeting multi-drug resistant infections. These investments underscore an unwavering focus on addressing unmet medical needs through innovative therapeutic solutions. Regulatory challenges persist as well; Unicycive Therapeutics faced FDA rejection due to third-party manufacturing deficiencies surrounding oxylanthanum carbonate. This setback emphasizes the critical importance of maintaining rigorous quality standards throughout drug production processes to secure regulatory approvals and ensure patient safety. Globally, China has achieved a milestone with the approval of the world's first CAR-T therapy for solid tumors—a significant leap forward given the historical challenges of applying CAR-T technology beyond hematological malignancies. This approval could transform cancer treatment paradigms globally and prompt similar regulatory advancements in other regions. In other developments, Abbvie and Genmab's combination therapy involving Epkinly has shown promise in diffuse large B-cell lymphoma (DLBCL) trials following prior challenges with monotherapy approaches. This success story highlights the potential of combination therapies in enhancing outcomes for patients battling complex cancers like DLBCL. From a corporate perspective, Klick Health's acquisition of Oxford Pharmagenesis marks its third purchase in 18 months, expanding its global footprint and scientific capabilities—a testament to ongoing consolidation trends aimed at augmenting expertise and strategic growth within the sector. These developments collectively paint a picture of an industry dynamically evolving amidst scientific breakthroughs and regulatory recalibrations. As companies navigate this transformative landscape, their ability to adapt and innovate remains paramount for sustaining growth and addressing global healthcare challenges effectively. Stakeholders must remain agile to seize opportunities while mitigating inherent risks in this high-stakes environment that increasingly prioritizes patient-centric innovations.Support the show

Public comments have closed on the 2026 AHIMA-ACDIS Query Practice Brief.In other words, the time to talk is over, and the time to listen has begun.During the next live edition of the popular Internet broadcast Talk Ten Tuesdays, produced by ICD10monitor, you can hear out senior healthcare attorney Richelle Marting as she leads a reflection session to review key themes from the Brief.She will also share her analysis of those themes, including the concept of a “compliant” and “non-compliant” query and the problem with referring to certain query formats as “leading.”If you have had claims denied by third-party payers for “non-compliant” queries or if you have wondered how your organization would respond to allegations of leading or non-compliant queries, you'll want to listen to this remarkable broadcast.What's changed? And what does it really mean to issue a “compliant” query in today's healthcare landscape?Listen and learn.Other well-known subject-matter experts will also join the broadcast with more news to report, including the following:• POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of California-Davis Medical Center, will share her point of view during the broadcast.• CDI Report: Cheryl Ericson will provide an update on all things clinical documentation integrity (CDI).• SDoH Report: Tiffany Ferguson will report on news happening at the intersection of compliance and medical record coding.• The Coding Report: Christine Geiger returns to Talk Ten Tuesdays to report on the latest coding news.

Chasity Wedgeworth & Rhiannon Yard are Co-Founders of CRAFT (Cannabis Regulatory Alignment Framework & Training), where they helps develop industry-led standards, workforce training, and regulatory solutions for the Texas hemp industry. Also joining the show is Nicholas Mortillaro COO and Consultant EVOKANNA LABS.https://blazednews.com/thc-challenge/

Today, I'm joined by Evan Quinn, co-founder and CEO of hiyo. A nonalcoholic social tonic with adaptogens, nootropics, and botanicals, hiyo has expanded from DTC to 11K+ retail locations nationwide. In this episode, we discuss building a new category around social wellness. We also cover: Music and culture partnerships The household penetration opportunity Creating a proprietary "float" feeling from functional ingredients Subscribe to the podcast → insider.fitt.co/podcast Subscribe to our newsletter → insider.fitt.co/subscribe Follow us on LinkedIn → linkedin.com/company/fittinsider  hiyo's Website: www.drinkhiyo.comhiyo's Instagram: https://www.instagram.com/drinkhiyo/  - The Fitt Insider Podcast is brought to you by EGYM. Visit EGYM.com to learn more about its smart fitness ecosystem for fitness and health facilities. Fitt Talent: https://talent.fitt.co/Consulting: https://consulting.fitt.co/Investments: https://capital.fitt.co/ Chapters: (00:00) Introduction (04:00) Company and founder story (05:25) College inspiration and founding (06:50) Social Tonic category definition (08:35) Avoiding mocktail positioning (10:45) Straddling three industries (12:20) The "float" concept (15:05) Early traction and social proof (16:30) DTC-to-wholesale transition (17:45) Retail expansion strategy (21:00) Music and culture partnerships (23:00) Ingredient philosophy (25:01) Staying disciplined on innovation (28:30) Regulatory compliance and quality (29:16) Category constriction and white space (31:30) Household penetration opportunity (34:00) Red Bull comparison and hiyo lifestyle (35:45) Meaning and ritual in wellness (36:30) Where to find (38:00) Conclusion  

In this crypto town hall show, Dave, Scott, and Peter Schiff discuss Michael Saylor and Strategy's new manifesto and market reaction. Topics include Strategy's long-term Bitcoin appreciation bet with no near-term selling or buying, 25-month reserves via preferreds, share repurchases, dividends, and capped BTC sales. They analyze MSTR outperforming in BTC rallies but lagging in flat markets, STRC as high-yield debt tied to future Bitcoin price, and dismissal of 2022-style forced liquidation waves. Crypto sentiment covers retail exodus and fear versus net platform buys and Solana's surprising strength and adoption. Ethereum foundation shifts are noted. The core debate examines token economics and valuations: Bitcoin as unmatched digital gold with superior security and global PoW access, versus utility tokens on Ethereum, Solana, Hyperliquid, single-use chains, and compute tokens potentially accruing value through fees, tokenization, or agentic commerce — or remaining narrative-driven distortions like the internet bubble, without real economics flowing to holders per DTCC-style analogies. Regulatory challenges around the Howey test and token pass-through are touched on, alongside a light Dogecoin versus Bitcoin exchange. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of Medsider Radio, we sat down with Aditya Rajagopal, co-founder and CEO of Esperto Medical.Esperto is a Caltech spin-out utilizing compressed sensing technology with ultrasound to continuously and non-invasively measure blood pressure.Before Esperto, Aditya co-founded ChromaCode, a molecular diagnostics company, and was a researcher at Google[x], where he worked on novel medical imaging methods. Aditya also serves as part-time faculty at Caltech and USC, and holds BS, MS, and PhD degrees in Electrical Engineering from Caltech. In this interview, Aditya discusses why great science doesn't necessarily make great companies, what it takes to win as a fast-follower in medtech, and how to sequence a platform technology without spreading resources too thin.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Aditya Rajagopal, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(02:44) - Aditya's journey from Caltech and Google to tackling one of medicine's hardest engineering problems at Esperto (05:17) - How Esperto is trying to solve a 50-year-old problem: continuous blood pressure monitoring without an arterial catheter (07:17) - Why Esperto was okay with being a fast-follower in an established market instead of creating a new one (16:12) - "Great science doesn't necessarily make great companies" and other lessons Aditya learned at ChromaCode (24:02) - Three hurdles every medical device must clear before clinicians will actually adopt it (27:44) - How Aditya determines whether a technical problem actually has a "there there" (37:51) - Esperto's pitch strategy and how it raised from a position of strength (43:18) - What first-time founders often misunderstand about how venture capital actually works

There's a method by which providers can avoid the snare of the latest claim denial strategy to garner attention. Much has been written about the Aetna policy for its “severity inpatient payment” element.Yet almost daily, providers appear to be turning to trusted sources to avoid pitfalls. And that is why the producers of RACmonitor's Monitor Mondays have invited physician and attorney Dr. John K. Hall to serve as special guest during the next edition of the venerable weekly national podcast.During this remarkable live Internet broadcast, Dr. Hall will unpack the issues that seem to flummox payers, resulting in a variety of actions, ranging from recoupment to reimbursement at lower levels (i.e. “observation” rates).Broadcast segments will also include these instantly recognizable features:• Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.• The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.• Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.• Legislative Update: Cate Brantley, legislative affairs analyst for Zelis, will report on current healthcare legislation.

On February 20, 2026, the Supreme Court invalidated the tariffs imposed under the International Emergency Economic Powers Act, or IEEPA. This introduced a new layer of uncertainty for global trade. As we all know, tariffs directly influence sourcing decisions, pricing, and broader supply chain strategy, so any shift in tariff authority or refund eligibility carries ... Read more The post [Video] Navigating The Post-IEEPA Regulatory Landscape appeared first on Talking Logistics with Adrian Gonzalez.

At first glance, hearing "We've never had a complaint" sounds like excellent news.No customer dissatisfaction.No product issues.No safety concerns.But for Quality and Regulatory professionals, this statement should trigger an entirely different question:How do you know?What Is a Complaint?Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word "complaint."Regulators take a much broader view.A complaint may include:Unexpected device performanceProduct malfunctionsCustomer dissatisfactionUsability issuesDistributor observationsTechnical support interactionsReturned productsAny information suggesting the device may not meet requirementsComplaints Are Often HiddenPotential complaint signals can be found in:Customer emailsDistributor communicationsService reportsSales team discussionsTraining sessionsSocial media commentsTechnical support ticketsIf these sources are ignored, valuable post-market information is lost.Why Zero Complaints Can Be a Red FlagImagine a company with:5,000 devices on the marketProducts sold in 20 countriesDaily clinical useAnd yet...No complaintsNo usability observationsNo customer questionsNo returned devicesExperienced auditors may not celebrate.Instead, they may question whether the complaint handling process is effective enough to capture real-world information.Complaint Handling Impacts the Entire Quality SystemWeak complaint collection doesn't only affect one procedure.It directly influences:Clinical Evaluation Reports (CER)Post-Market Surveillance (PMS)PMCF activitiesPSUR preparationBenefit-Risk assessmentsState-of-the-art reviewsIf complaint data is incomplete, clinical evidence may also be incomplete.Five Practical RecommendationsDefine complaints broadly.Review every customer-facing information source.Create a structured complaint screening process.Trend data regularly to identify recurring issues.Periodically challenge your system by asking:"Would an auditor agree that we've identified every potential complaint?"Final ThoughtThe next time someone proudly says,"We've never had a complaint,"don't celebrate immediately.Ask instead,"How do we know?"Because in medical devices, the absence of complaints is not always evidence that everything is working perfectly.Sometimes, it's evidence that nobody is looking.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Charles Schwab's Adam Lynch discusses the latest moves in Bitcoin, highlighting that the cryptocurrency has broken its 200-week moving average. He also examines the factors weighing on cryptocurrencies, what investors should know about the Clarity Act, and its potential impact on the digital asset industry.======== Schwab Network ========Empowering every investor and trader, every market day.Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about

It hasn't been in many headlines (thanks, AI), but pharmaceutical companies are on a merger & acquisition spree that could break records. With more than $126 billion in deals so far this year, companies are looking for novel drug canddiates and clinical stage companies to bolster their own development pipeline. We'll take a dive into what's driving this M&A frenzy and what companies look interesting in the pharmaceutical space today.Tyler Crowe, Matt Frankel, and Lou Whiteman discuss:- Big Pharma using big wallets for M&A- Who's at risk of running off a patent cliff- Regulatory changes adding fuel to the fire- Companies doing great for patients (and investors)- Mailbag: Is Pfizer ok? Companies discussed: LLY, MRK, UTHR, ASND, PFE, ABBV, GSK, NVO, RHHBYHost: Tyler CroweGuests: Matt Frankel, Lou WhitemanEngineer: Bart Shannon Disclosure: Advertisements are sponsored content and provided for informational purposes only. The Motley Fool and its affiliates (collectively, “TMF”) do not endorse, recommend, or verify the accuracy or completeness of the statements made within advertisements. TMF is not involved in the offer, sale, or solicitation of any securities advertised herein and makes no representations regarding the suitability, or risks associated with any investment opportunity presented. Investors should conduct their own due diligence and consult with legal, tax, and financial advisors before making any investment decisions. TMF assumes no responsibility for any losses or damages arising from this advertisement. We're committed to transparency: All personal opinions in advertisements from Fools are their own. The product advertised in this episode was loaned to TMF and was returned after a test period or the product advertised in this episode was purchased by TMF. Advertiser has paid for the sponsorship of this episode. Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

Jack Burnham examines the Pentagon's 1260H list, which identifies Chinese companies allegedly assisting the PRC's military-industrial base, signaling increased regulatory scrutiny for these entities. Burnham recommends streamlining government lists to prevent companies from exploiting gaps and advises retail investors of the national security risks these firms pose. (6)1919