Podcasts about regulatory

In this episode, Elliot Berman and John Byrne break down the major developments from the February FATF Plenary, including Kuwait and Papua New Guinea joining the Grey List and updates on evaluations for Austria, Italy, and Singapore. They also explore FATF leadership changes and the reiteration of Russia's suspension. The conversation moves into rising crypto-enabled human trafficking networks highlighted in a new report from Chainalysis, Cambodia's large-scale crackdown on fraud centers, and several key U.S. regulatory updates. These include FinCEN's new CDD “exceptive relief,” the rollout of a whistleblower portal, and the OCC's proposed changes to the bank appeals process. Elliot and John also discuss recent law enforcement actions, Supreme Court efforts to strengthen conflict-of-interest checks, and a Federal Reserve governor's insight into how AI may reshape the labor market.

In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.We cover:Understanding Defects in SaMD• What defines a defect in a regulated context• How defect management differs from non-medical software• The relationship between defects, risk management, and ISO 14971Building a Compliant Defect Management Process• Essential documentation and tools• Severity and priority categorization• Handling defects discovered during validation or post-market• Differentiating between defects, change requests, and requirement gapsAdvanced & Real-World Scenarios• Managing safety-critical defects• When CAPA or vigilance reporting is required• Handling SOUP and third-party component issues• Ensuring traceability across versions and product variants• Agile defect management strategiesAudit Perspective & Common Pitfalls• Frequent gaps identified by regulators and notified bodies• How defect trend data supports CAPA and management review• Practical advice for startups implementing lightweight but compliant systemsWe also discuss how modern eQMS platforms (such as SmartEye) can help streamline documentation, automate traceability, and improve oversight without adding unnecessary bureaucracy.Defect management in SaMD is not about documentation — it's about maintaining control over risk and ensuring safe, effective software throughout its lifecycle.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.LinkSimon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/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 powered by Podcastics, the easiest platform to create and publish your podcast.

Brian Whorley, Founder and CEO of Paytient, is rebuilding healthcare's broken payment infrastructure. Paytient enables employers and insurers to front healthcare costs for members who repay over time, interest-free. The company now serves 6,000 employers and powers payment solutions for nearly half of America's 50 million Medicare seniors. In this episode of BUILDERS, Brian reveals his counterintuitive GTM pivot from employers to insurers, why he testified before Congress on healthcare affordability, and how to build in highly regulated markets without fighting the system. Topics Discussed: Why healthcare lacks functional buyer-seller dynamics and transparent pricing The World War II tax quirk that prevents employers from giving healthcare dollars directly to employees Cash market case studies: Why LASIK prices decreased in real terms since 1998 while maintaining quality improvements Paytient's unexpected discovery that insurers were better strategic partners than employers Congressional testimony before the House Committee of Oversight and Government Reform on December 10th The company's evolution from founder-led employer sales to insurance-first distribution strategy Launching self-serve for sub-200 employee companies while closing Fortune 100 accounts How Medicare regulations requiring prescription payment flexibility created a 50-million-person market GTM Lessons For B2B Founders: Test enterprise distribution earlier than your assumptions suggest: Brian assumed Paytient needed a million users before insurers would engage. Instead, one of the nation's largest insurers partnered early because they recognized out-of-pocket costs as a critical experience gap they couldn't solve internally. The insurer's product team understood the problem but lacked control over member finances. When building in complex ecosystems, large strategic partners may engage earlier than expected if you solve a problem outside their core capabilities. Prioritize partners with longer planning horizons: Brian discovered insurers planning 2027-2029 health plans in early 2025, while employers focused on last month's challenges. This planning horizon difference fundamentally changed Paytient's GTM strategy. Insurers became the majority of their business because they could "invest and reshape for the long term" as part of broader strategy. When choosing between customer segments, prioritize buyers who think strategically over those managing tactical, short-term needs—they'll invest in solutions before acute pain points emerge. Regulatory tailwinds can create massive distribution overnight: A law passed four years after Paytient launched required all Medicare insurers to offer exactly what Paytient provides—prescription cost flexibility with insurer-fronted payments. This regulation instantly created a 50-million-person addressable market. Brian now powers this for "almost half the country." When building in regulated industries, track pending legislation that could mandate your solution category, creating instant distribution through compliance requirements. Build different GTM engines for concentrated vs. fragmented markets: Healthcare is "a very concentrated industry" at the top 40 insurers, where Paytient focuses enterprise efforts. For the fragmented small business market (under 200 employees), they launched a self-serve platform at patient.com this month, immediately gaining traction with venture-backed employers seeking simple subscriptions. The dual-motion approach—high-touch for concentrated markets, self-serve for long-tail—maximizes coverage without burning capital on inefficient sales motions. In trust-based sales, delivery quality drives expansion velocity: When Paytient launches with a Fortune 100, "tens of thousands of people have access to patient now." The benefits stack is "sacred and sacrosanct"—a trust-based, relationship-driven sale. Brian emphasizes the product must work "exactly how you said, even better" because performance creates referrals through benefit brokers and consultants. In high-stakes enterprise deployments, your product quality directly determines sales velocity through partner and customer networks. Navigate regulatory constraints as creative boundaries, not barriers: Brian's core advice for healthcare founders: "You have to work with the system as it is." Many founders approach healthcare "as antagonist" with solutions "too foreign or too different" that threaten the status quo. Instead, innovate within existing regulatory and operational frameworks. There are "plenty of space" and "data requirements for how healthcare can work today" to build billion-dollar businesses while respecting industry structure. Fighting the system guarantees slow adoption; working within it enables scale. // Sponsors: Front Lines — We help B2B tech companies launch, manage, and grow podcasts that drive demand, awareness, and thought leadership. www.FrontLines.io The Global Talent Co. — We help tech startups find, vet, hire, pay, and retain amazing marketing talent that costs 50-70% less than the US & Europe. www.GlobalTalent.co // Don't Miss: New Podcast Series — How I Hire Senior GTM leaders share the tactical hiring frameworks they use to build winning revenue teams. Hosted by Andy Mowat, who scaled 4 unicorns from $10M to $100M+ ARR and launched Whispered to help executives find their next role. Subscribe here: https://open.spotify.com/show/53yCHlPfLSMFimtv0riPyM

In this episode, we explore how artificial intelligence is revolutionizing HR, with a focus on building trust through data privacy and security. Join us as we discuss practical steps, emerging challenges, and the evolving role of HR professionals in the AI era. Key Topics: The importance of foundational data quality before implementing AI in HR Securing sensitive employee data and managing privacy concerns The role of semantic layers and data organization for effective AI use How AI impacts HR workflows and transforms knowledge work Practical approaches to integrating AI responsibly and securely Education needs for HR to understand AI risks and opportunities Future trends: AI's potential to reinvent HR practices, not just automate Resources & Links: Fuel 50 - Workforce Mobility and Talent Pipelines Amazon - Book: Data Privacy and Security in the Cloud Flurry - Official Website Amazon Bedrock - AI Model Service Anthropic - AI Safety and Privacy Guarantees OpenAI - Responsible AI Use Connect with Brian Platts: LinkedIn Twitter Timestamps:  00:30 - Welcome and introduction to the episode 01:15 - Brian Platts' background in HR and software 02:08 - Flurry's mission to make data meaningful for HR 03:26 - Fun fact: starting career driving a semi truck 04:44 - AI in HR: privacy, security, and data foundations 05:53 - Preparing your HR data for AI adoption 06:08 - Challenges with data quality and use cases 07:08 - Security considerations: private vs. public data 08:22 - Trusting AI vendors and data-sharing risks 09:15 - Teaching AI to query data securely 10:07 - Data organization and semantic layers 11:29 - Improving chatbots and avoiding misinformation 12:26 - Ensuring process accuracy and data integrity 13:14 - Sharing vs. protecting employee data 14:05 - Re-implementing permissions in AI-driven systems 15:01 - Education and awareness around AI security 16:13 - Learning from SaaS security issues during early cloud adoption 17:18 - HR's role in AI education and safeguarding IP 18:14 - Balancing productivity gains with security controls 19:06 - AI's impact on HR future: automation and new workforce roles 20:16 - The concept of the “Meat Layer” and human-AI collaboration 21:02 - Will AI replace HR jobs or empower them? 22:16 - The limits of current AI technology and future innovations 23:03 - Analogies: AI as a horse and the importance of tooling 24:06 - Embracing AI to enhance human work rather than replace it 25:16 - Reinventing HR processes beyond IT-led automation 26:18 - Regulatory challenges and incremental HR AI adoption 27:30 - How HR can lead responsible AI integration 28:03 - Final advice for HR professionals: think broadly and connect the dots

Gm! In today's episode we are joined by Kristin Smith to discuss her transition to the Solana Policy Institute, recent U.S. crypto policy shifts, and progress under the Genius Act. We also discuss the CLARITY Act, market structure reform, DeFi and developer protections, institutional adoption, and the importance of durable regulatory clarity. Enjoy! -- Follow Lightspeed: ⁠https://twitter.com/Lightspeedpodhq⁠ Follow Solana Policy Institute: https://x.com/SolanaInstitute Follow Kristin Smith: https://x.com/KristinSmith Follow Danny: https://x.com/defi_kay_ Join the Lightspeed Telegram: ⁠https://t.me/+QHlbNTNS4gc1ZTVh -- Join us at DAS (Digital Asset Summit) in New York City this March!  Use the link below to learn more, and use code LIGHTSPEED200  to get $200 off your ticket! See you there! Learn more + get your ticket here: https://blockworks.co/event/digital-asset-summit-nyc-2026 -- Get top market insights and the latest in crypto news. Subscribe to Blockworks Daily Newsletter: https://blockworks.co/newsletter/ -- Timestamps: (0:00) Introduction (3:01) Kristin Smith's Move to Solana (7:57) Crypto's Regulatory Turning Point (14:59) CLARITY Act & Market Structure (29:37) Protecting DeFi Developers (35:54) Institutional Access to Crypto (40:55) The Path to Lasting U.S. Crypto Clarity (50:49) Closing Comments -- Disclaimers: Lightspeed was kickstarted by a grant from the Solana Foundation. Nothing said on Lightspeed is a recommendation to buy or sell securities or tokens. This podcast is for informational purposes only, and any views expressed by anyone on the show are solely our opinions, not financial advice. Danny, and our guests may hold positions in the companies, funds, or projects discussed.

What if robots could handle tedious retraction, precise bone milling, or even autonomous suturing, freeing surgeons to focus on complex decision-making and more patients?In this episode of the Succeed In Medicine Podcast, Dr. Bradley Block speaks with Dr. Michael Yip, as he explains that today's robots primarily serve as extensions of human surgeons via teleoperation (e.g., da Vinci for precision in hard-to-reach areas), enhancing dexterity, visualization, and accuracy rather than replacing them. He highlights existing autonomous applications in "hard tissue" procedures like the Mako or Stryker robots for precise bone milling in joint replacements, and non-contact examples like CyberKnife for focused radiation therapy.For soft tissue surgery, the more challenging domain due to tissue deformation and variability, autonomy is emerging in simpler, repetitive tasks such as retraction, suctioning, or basic suturing, with demonstrations dating back 15 years but real-world deployment lagging due to engineering, data, and economic hurdles. Dr. Yip discusses why demos in controlled settings don't easily translate to ORs, the shift to data-driven AI (with risks of out-of-distribution failures), and regulatory challenges like FDA expertise gaps and defining probabilistic safety. He predicts stepwise adoption: starting with assistant-level tasks (replacing med student/intern roles in retraction/suction), then progressing to free surgeons for higher-value work, especially in underserved rural areas via telesurgery. Full "skin-to-skin" autonomy (e.g., simple lipoma excision or appendectomy) remains years away, limited by hardware combining strength, dexterity, and precision in one system, though teams of specialized robots could accelerate progress. Ultimately, robotics will alleviate surgeon burnout from growing demand, not eliminate jobs soon.Three Actionable TakeawaysEmbrace Robotics Early in Training: Surgeons and trainees should gain hands-on experience with diverse robotic technologies now, treating them as essential tools that augment precision and dexterity rather than threats to obsolescence.Focus on Repetitive Tasks for Autonomy Gains: Prioritize robotic assistance in tedious, physically demanding steps like retraction, suctioning, or basic closure to free up time, reduce fatigue, and improve efficiency in high-volume or resource-limited settings.Stay Informed on Regulatory and Economic Shifts: Monitor evolving FDA guidelines for AI/surgical autonomy, economic incentives (e.g., cost savings in joint replacements or anastomosis), and liability frameworks to prepare for integration that enhances patient access and outcomes.About the Show:Succeed In Medicine covers patient interactions, burnout, career growth, personal finance, and more. If you're tired of dull medical lectures, tune in for real-world lessons we should have learned in med school!About the Guest:Dr. Michael Yip is an Associate Professor of Electrical and Computer Engineering at UC San Diego and Director of the Advanced Robotics and Controls Laboratory (ARCLab). His research focuses on surgical robots, biomimetic design, robot learning, autonomous robotic surgery, and deformable tissue manipulation. He has received the NSF CAREER Award, NIH Trailblazer Award, IEEE RAS Distinguished Lecturer recognition, and was named Faculty Innovator of the Year at UCSD in 2024 and elected to the National Academy of Inventors. Previously a Disney researcher at Amazon Robotics, he holds a BSc in Mechatronics Engineering from the University of Waterloo, MS in Electrical Engineering from the University of British Columbia, and PhD in Bioengineering from Stanford University.Website: yip.eng.ucsd.edu and ucsdarclab.comAbout the Host:Dr. Bradley Block – Dr. Bradley Block is a board-certified otolaryngologist at ENT and Allergy Associates in Garden City, NY. He specializes in adult and pediatric ENT, with interests in sinusitis and obstructive sleep apnea. Dr. Block also hosts Succeed In Medicine podcast, focusing on personal and professional development for physiciansWant to be a guest?Email Brad at brad@physiciansguidetodoctoring.com  or visit www.physiciansguidetodoctoring.com to learn more!Socials:@physiciansguidetodoctoring on Facebook@physicianguidetodoctoring on YouTube@physiciansguide on Instagram and Twitter   This medical podcast is your physician mentor to fill the gaps in your medical education. We cover physician soft skills, charting, interpersonal skills, doctor finance, doctor mental health, medical decisions, physician parenting, physician executive skills, navigating your doctor career, and medical professional development. This is critical CME for physicians, but without the credits (yet). A proud founding member of the Doctor Podcast Network!Visit www.physiciansguidetodoctoring.com to connect, dive deeper, and keep the conversation going. Let's grow! Disclaimer:This podcast is for informational purposes only and is not a substitute for professional medical, financial, or legal advice. Always consult a qualified professional for personalized guidance. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

If you're a physician with at least 5 years of experience looking for a flexible, non-clinical, part-time medical-legal consulting role… ...Dr. Armin Feldman's Medical Legal Coaching program will guarantee to add $100K in additional income within 12 months without doing any expert witness work. Any doctor in any specialty can do this work. And if you don't reach that number, he'll work with you for free until you do, guaranteed. How can he make such a bold claim? It's simple, he gets results…  Dr. David exceeded his clinical income without sacrificing time in his full-time position. Dr. Anke retired from her practice while generating the same monthly consulting income.  And Dr. Elliott added meaningful consulting work without lowering his clinical income or job satisfaction. So, if you're a physician with 5+ years of experience and you want to find out exactly how to add $100K in additional consulting income in just 12 months, go to arminfeldman.com.                                                          =============== Get the FREE GUIDE to 10 Nonclinical Careers at nonclinicalphysicians.com/freeguide. Get a list of 70 nontraditional jobs at nonclinicalphysicians.com/70jobs.                                                                                                 =============== Regulatory medical writer Dr. Keagen Hadley explains how a pre-med background, clinical research work at a small CRO, and graduate training in occupational therapy led him into a fully remote, high-earning career writing core documents for pharma and biotech. He describes how he first discovered regulatory writing, why it felt like the right balance of science, impact, and flexibility, and how that path allowed him to work, study, and eventually step away from traditional clinical roles. He then outlines what regulatory writers actually do: drafting protocols, investigator brochures, and clinical study reports. And why the work is a strong fit for clinicians who enjoy clear, technical writing and are willing to learn the drug-development process. Along the way, he talks about salary expectations, personality traits that help (discipline, proactivity, comfort with timelines), and the practical steps clinicians can take to move into the field and eventually build their own regulatory writing business. You'll find links mentioned in the episode at nonclinicalphysicians.com/regulatory-medical-writing/

For episode 677 of the BlockHash Podcast, host Brandon Zemp is joined by Parth Kapadia, Co-founder and CEO of OpenVPP.OVPP is Building The Internet of Energy by Providing Regulated Digital Asset Rails for Power & Utility Providers. OpenVPP is led by Co-Founder & CEO, Parth Kapadia. Parth brings a wealth of experience from the electric utility industry, including roles at Exelon Corp and AutoGrid (acquired by Uplight, a Schneider Electric company), where he served as Director of Technical Product Management.

In this episode of Medsider Radio, we sat down with Shaun Bagai, CEO of RenovoRx. The company is developing targeted oncology therapies and is currently commercializing RenovoCath, which is focused on pancreatic cancer. Before joining RenovoRx in 2014, Shaun spent over a decade in the cardiovascular space, including leading global market development at HeartFlow and helping establish the European renal denervation market at Ardian, which Medtronic acquired for approximately $1 billion. He began his career in clinical research and device sales at TransVascular and Medtronic. In this interview, Shaun discusses how testing markets with minimal infrastructure reveals what leads to commercial success, why clinical trial enrollment benefits from sales discipline, and what founders should understand about going public when traditional capital isn't available.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 Shaun Bagai.

Once a relic symbolic of earlier times in medicine, the Inpatient-Only (IPO) List has been added to the junkyard of outdated medical processes and practices. And if you and your team fail to plan and align your system appropriately, you risk major financial, operational, and compliance consequences.The good news: during the next live edition of Monitor Mondays, you'll learn why inpatient status is no longer guaranteed by procedure. You'll also learn how the burden of proof for inpatient care now rests in your documentation, along with what you and your team must do to protect appropriate inpatient admissions. Join us when Dr. Stephanie Van Zandt reveals practical strategies to navigate this new landscape and stay ahead of the curve.Broadcast segments will also include these instantly recognizablepanelists, who will report more news during their segments:·      POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of Davis Medical Center, will share her point of view during the broadcast.·      CDI Report: Cheryl Ericson will provide an update on clinical documentation integrity (CDI).·      The Coding Report: Christine Geiger will report on the latest coding news.·      News Desk: Juliet Ugarte Hopkins, MD will anchor the Talk Ten Tuesdays News Desk.

A former EPA chief discusses pollution and public health after the Trump administration reverses a landmark federal endangerment rule.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events and decisions in the industry that are shaping the path forward for drug development and patient care.The U.S. Food and Drug Administration (FDA), an agency often at the center of pharmaceutical innovation and scrutiny, has recently made several noteworthy decisions. These decisions not only point to the ongoing regulatory challenges but also highlight scientific advancements within the field.One of the key updates involves the FDA's decision to reject Disc's drug bitopertin, which was intended for the treatment of erythropoietic protoporphyria, a rare blood disease. Despite receiving a national priority voucher for expedited review, the FDA ultimately concluded that the clinical data did not sufficiently support regulatory approval. This decision underscores the FDA's commitment to maintaining rigorous standards even when expedited reviews are in play, emphasizing the necessity of robust clinical evidence for approval.Adding complexity to this situation is the internal dynamics within the FDA itself. Richard Pazdur, a long-standing official at the agency, recently stepped down, revealing disagreements with Commissioner Marty Makary over reducing the number of clinical trials required for new drug applications. Pazdur's departure after an influential 26-year tenure highlights ongoing debates within regulatory bodies on how to balance innovative approval pathways with ensuring safety and efficacy data.In another notable development, Moderna faced setbacks with its mRNA-1010 flu vaccine as the FDA declined to review it. This decision leaves American consumers without access to potentially more effective mRNA-based flu vaccines—a technology embraced by other countries for influenza treatment. This situation points to possible missed opportunities in leveraging cutting-edge vaccine technologies domestically, showcasing both the promise and regulatory complexities surrounding mRNA technology.These regulatory challenges unfold amid leadership changes and strategic shifts within health agencies. For instance, Jim O'Neill's departure from his role as acting director of the Centers for Disease Control and Prevention following Susan Monarez's abrupt ouster illustrates how leadership turbulence can impact policy consistency and strategic direction, potentially affecting how new health initiatives are prioritized and implemented.Meanwhile, companies like Vertex and CRISPR Therapeutics are ambitiously advancing gene therapy solutions such as Casgevy, signaling a broader trend towards personalized medicine and advanced biotechnological approaches. These efforts promise transformative impacts on patient care and reflect an industry-wide move towards precision medicine.Eli Lilly's substantial investment in orforglipron stock ahead of its anticipated approval further indicates confidence in their product pipeline amidst growing competition from Novo Nordisk's Wegovy pill abroad. This competitive landscape highlights increasing interest and investment in innovative treatments for metabolic diseases.Overall, these developments illustrate a dynamic interplay between scientific innovation, regulatory scrutiny, and strategic corporate maneuvers that shape healthcare's future. As companies push technological boundaries, regulators face ongoing challenges in adapting frameworks that ensure patient safety while fostering innovation. The outcomes of these processes will significantly influence not only patient access to cutting-edge therapies but also set precedents for future drug development and approval pathways. As these trends unfold, stakeholders across the industry must remain agile, informed, and collaborative to navigate this evolving landscape effectively.Looking back at 2025, it was a tSupport the show

The conversation explores the intersection of Bitcoin mining, AI, and national security, emphasizing the importance of educating policymakers about the benefits of Bitcoin mining for grid resiliency and community engagement. The speakers discuss actionable steps for industry professionals to effectively engage with policymakers, highlighting the need for transparency, collaboration, and proactive communication.TakeawaysBitcoin mining is crucial for national security and grid resiliency.Education is key in engaging with policymakers.Policymakers are increasingly interested in the benefits of Bitcoin mining.Building trust with local communities is essential for Bitcoin operations.The intersection of Bitcoin mining and AI presents new opportunities.Operators should be proactive in addressing concerns of policymakers.Collaboration with trade associations can amplify industry voices.Bringing hardware to meetings can help demystify Bitcoin mining.It's important to focus on community benefits when discussing operations.Engaging with policymakers can be a rewarding experience.Chapters00:00 Introduction to Bitcoin Policy and Experts02:34 Intersection of Bitcoin Mining, AI, and National Security10:07 The Role of Bitcoin Mining in Grid Resiliency16:20 Building Trust with Policymakers23:39 Actionable Steps for Engaging PolicymakersKeywordsBitcoin, policy, mining, AI, national security, grid resiliency, education, engagement, community, trust

Chris Yin is CEO/Co-Founder of Plume Network, the first permissionless, full-stack blockchain built for real-world asset finance (RWAfi). He spearheads the team shaping the infrastructure and policy standards to accelerate the development of onchain capital markets. Chris has an accomplished track record as a founder and investor in the enterprise software space, with tenures at Scale Venture Partners, Rainforest QA, and Xpenser (acquired by Coupa, IPO 2016). In this conversation, we discuss:- Current price action is just short term pain - What to expect from RWAs in 2026 - DeFi opportunities in RWAs - Plume's differentiator - Regulatory developments in RWAs - Optimizing Looping - Onchain asset management - This history of technology - Nest vaults on Solana - Building Key TradFi partnerships - User experience is everything Plume NetworkX: @plumenetworkWebsite: www.plume.orgTelegram: t.me/plumenetwork_communityChris YinX: @chriseyinLinkedIn: Chris Yin---------------------------------------------------------------------------------This episode is brought to you by PrimeXBT.PrimeXBT offers a robust trading system for both beginners and professional traders that demand highly reliable market data and performance. Traders of all experience levels can easily design and customize layouts and widgets to best fit their trading style. PrimeXBT is always offering innovative products and professional trading conditions to all customers.  PrimeXBT is running an exclusive promotion for listeners of the podcast. After making your first deposit, 50% of that first deposit will be credited to your account as a bonus that can be used as additional collateral to open positions. Code: CRYPTONEWS50 This promotion is available for a month after activation. Click the link below: PrimeXBT x CRYPTONEWS50FollowApple PodcastsSpotifyAmazon MusicRSS FeedSee All

JFSA's Katsuya Terai on Japan's crypto shift toward FIEA, upcoming disclosure rules, stablecoin pathways, and insider trading plans.

In a January 28 article, Dr. Ronald Hirsch verified that the Centers for Medicare and Medicaid Services (CMS) “has no problem” with the Aetna Severity Payment policy because it “meets the Two-Midnight Rule.” However, there is more to consider than compliance with 42 CFR 412.3. Federal regulations also state Medicare Advantage organizations must comply with Traditional Medicare laws including payment criteria for inpatient admissions at 42 CFR 422.101(b)(2). So the burning question remains: Is CMS disregarding pertinent regulations that could nullify Aetna's policy?During the next live edition of the venerable Monitor Monday, the Internet broadcast, Cheryl Ericson, senior director of clinical policy and education for the Brundage Group, will address this apparent contradiction.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 liaison for Zelis, will report on current healthcare legislation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events shaping the landscape of drug development, regulatory scrutiny, and industry advancement. As we navigate this complex terrain, we'll explore how these changes impact both companies and patients.In recent news, Moderna has encountered a substantial hurdle as the FDA declined to review its flu vaccine candidate, mRNA-1010. This decision marks a notable shift from the expedited processes witnessed during the COVID-19 pandemic, reflecting a more cautious regulatory approach under current administrative leadership. Analysts suggest this could indicate broader regulatory changes that might affect future vaccine approvals. Moderna's situation is emblematic of the challenges companies face in maintaining momentum post-pandemic, especially as their research and development spending saw a significant decrease of 31% last year due to completed respiratory trials. This reduction highlights a strategic pivot as the company reassesses its priorities amidst an evolving market landscape.Vertex Pharmaceuticals is making headlines with its ambitious revenue goals outside its established cystic fibrosis franchise. By 2026, Vertex aims to generate $500 million from non-CF medications, with recent launches like Casgevy and Journavx already showing promise by collectively bringing in $175.6 million last year. This diversification strategy is critical for mitigating risks associated with dependence on a single therapeutic area and reflects a broader industry trend towards strategic realignment. Additionally, Vertex remains under close observation within kidney disease portfolios, particularly with Povetacicept—an IgA nephropathy treatment—and the success of Journavx impacting market positions by offering chronic kidney disease patients new therapeutic options.PTC Therapeutics has faced setbacks with its FDA application withdrawal for Translarna, intended for treating nonsense mutation Duchenne muscular dystrophy. The decision came after receiving adverse feedback from the FDA, highlighting the complexities involved in gaining approval for therapies targeting intricate genetic conditions. Such hurdles underscore the high-risk nature of biotech ventures that are heavily reliant on regulatory timelines.Novartis is pushing forward with plans to seek full FDA approval for Vanrafia, its IgA nephropathy drug, despite not meeting primary kidney function goals in Phase 3 trials. This move aligns with a growing trend where companies pursue approval based on secondary endpoints or other supportive data when primary outcomes fall short. Such strategies underscore the competitive and high-stakes environment surrounding drug approval pathways.Novo Nordisk is expanding its production capabilities in Ireland to meet increasing demand for Wegovy, their obesity drug that's seen impressive sales in the U.S. This investment underscores the global potential for obesity treatments and highlights how manufacturing expansions are pivotal to supporting international market entry.In Europe, Amgen has secured approval for Uplizna in treating myasthenia gravis, adding another option to an already crowded treatment landscape but offering patients additional therapeutic choices. Meanwhile, AbbVie has launched a legal challenge against Botox's inclusion in drug pricing negotiations under the Inflation Reduction Act (IRA), arguing it should be excluded due to its plasma-derived nature.Ultragenyx has announced a 10% workforce reduction amid halted gene therapy plans and unsuccessful late-stage trials in brittle bone disease. These adjustments often reflect broader strategic shifts within biopharma companies as they realign focus and resources. Ultragenyx's operational challenges highlight the volatile nature of biotech ventureSupport the show

Regulatory sandboxes allow startups to experiment with AI technologies in a controlled setting, fostering innovation while maintaining oversight. Joseph Joshy from IFSCA highlights their importance at the India AI Impact Summit 2026, noting they help balance innovation with risk management. Industry leaders discuss the need for India-specific AI protocols and emphasize the role of digital infrastructure in AI advancement.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

Bob Zimmerman covers ESA's fast-tracked Apophis asteroid mission, a commercial attempt to rescue a NASAtelescope, and the contrasting regulatory environments of the UK and New Zealand for space launches.

Recent weeks have seen extreme cross‑asset volatility, with sharp unwinds hitting US and China tech stocks, precious metals and cryptocurrencies. In China, renewed concerns about regulatory scrutiny are weighing on sentiment, even as the case for a stronger renminbi continues to build.In this episode of Moving Markets: The View Beyond, Richard Tang, Head of Research Hong Kong at Julius Baer, speaks with Hong Hao, Managing Partner and CIO of Lotus Asset Management Ltd., to discuss what the market dislocations mean for investors, and how these cross-asset dynamics may shape positioning in the weeks ahead.(00:30) - The big precious metals selloff (04:04) - Cryptocurrencies – near and long-term outlook (08:13) - Industrial metals remain supported by rising strategic demand (10:36) - China tech – is it time to buy the dip? (13:55) - Defining “value” in China's rotation (15:32) - Regulatory scrutiny – how worried should investors be? (20:20) - A-shares vs H-shares in the short term? (23:03) - Renminbi strength and outlook

If one man may legally own another, then he should likewise have the right to disown this property. To deny this right by law involves simultaneously affirming the right of one human to own another as his property but not the right to stop owning another human.Original article: https://mises.org/mises-wire/olaudah-equianos-manumission-regulatory-barriers-freedom

Marc Elovitz is Global Head of Investment Management Regulatory at McDermott Will & Schulte – a leading global law firm. Marc advises private fund managers on running their businesses consistent with all relevant laws, regulations and legal requirements. Marc's cutting-edge work also covers the latest trends of interest to private funds, including blockchain technology and digital assets. He advises on the legal and regulatory considerations involving virtual and digital currency business initiatives and the blockchain technology behind them. In this podcast, we discuss: From Litigation to Regulation The Private Market Boom "Project Crypto" and Regulatory Harmonisation Beyond Digital Gold The Yield Obstacle in Stablecoins Future-Proofing Digital Assets The Trust Factor in Private Equity Solving the AI Explainability Crisis The Delaware Governance Battle Perspective through Fiction

In this episode of Aerospace Unplugged, our host Adam Kress is joined by Pulkit Agrawal, Certification and Regulatory Affairs Leader for Advanced Air Mobility (AAM) at Honeywell Aerospace, and Devin Patterson, Director of Strategic Engagement at Southwest Mission Accelerator Center (MAC). Together, they take a deeper look at the rapidly evolving regulatory landscape that's shaping advanced air mobility, discussing the current progress and challenges, as well as shifting policies across different government levels, and more. Episode HighlightsCurrent Industry Developments, Needs, and Challenges: Explore how Federal Aviation Administration (FAA) initiatives, such as the EIPP program, are enabling early AAM operations, supporting data-driven rulemaking, and influencing collaboration among OEMs, regulators, and regional stakeholders.State of the AAM U.S. Regulatory Landscape: Learn what the U.S. regulatory approach for advanced air mobility is, including an overview of the national AAM strategy and how programs like EIPP fit into the broader effort to scale safe, early operations.Industry Collaborations & Their Significance: Discover how collaboration among industry, municipalities, states, and federal agencies is growing and how it's helping align infrastructure planning, policy development, and community engagement to support AAM deployment.Future Outlook for Advanced Air Mobility: Get a forward-looking view of what to the future may hold as AAM progresses toward broader operations, spanning regulatory frameworks, infrastructure readiness, public acceptance, and more.(No character limit / Highlights)

Digital health is no longer in its honeymoon phase. The funding boom is over. AI hype is everywhere. Health systems are overwhelmed. And startups can no longer survive on compelling pitch decks alone. In this episode of Faces of Digital Health, Tjaša Zajc speaks with Ruchi Dass, a former dental surgeon turned public health leader, policy contributor, investor, and advisor to startups scaling across the US, UK, India, Africa, and the Middle East. Ruchi describes a fundamental change in go-to-market (GTM) strategy: Workflow integration is non-negotiable (standalone apps struggle). Reimbursement clarity is critical. Regulatory strategy is part of GTM, not an afterthought. Time stamps: 00:06 – Introduction: startups, global markets, and unconventional careers 01:18 – From dental surgery to global public health and digital health 03:05 – The GTM shift: from promise to proof 04:49 – Staying investable: the four pillars 08:22 – AI ROI: clinical vs operational value 12:17 – Enterprise scaling and “sell to the mindset” 15:05 – Responsible AI: transparency, bias, and lifecycle regulation 19:56 – Predictability vs black-box AI in medicine 22:44 – Global innovation differences: Europe, India, Middle East, Africa 26:21 – Pilotitis: why pilots fail to scale 28:40 – Designing pilots for commercialization 30:26 – Capital flows, geopolitics, and reverse innovation 34:25 – The $1 teleconsultation model in India 37:56 – Digital health and equity: design vs digitization 42:43 – How regulators can keep up with AI 46:03 – Advice for Gen Z and Gen Alpha in digital health 48:50 – Grassroots realities shaping policy Watch the full discussion: https://youtu.be/bmvPzz3Ffp4 www.facesofdigitalhealth.com Newsletter: https://fodh.substack.com/

If one man may legally own another, then he should likewise have the right to disown this property. To deny this right by law involves simultaneously affirming the right of one human to own another as his property but not the right to stop owning another human.Original article: https://mises.org/mises-wire/olaudah-equianos-manumission-regulatory-barriers-freedom

Interview with Nolan Peterson, CEO of Atlas SaltOur previous interview: https://www.cruxinvestor.com/posts/atlas-salt-tsxvsalt-developer-targets-north-americas-30-40-de-icing-salt-supply-gap-8975Recording date: 5th February 2026North America faces a growing crisis in road salt supply that most investors have overlooked. While the US$26 billion global salt market operates largely beneath public awareness, severe winter weather across the northeastern United States and Canada has exposed a structural deficit that has persisted for decades. Atlas Salt (TSXV:SALT) is developing the Great Atlantic Salt Project in western Newfoundland—the continent's first new salt mine in nearly 30 years—to address this critical infrastructure gap.The North American deicing road salt market imports 8-10 million tons annually to meet demand that domestic production cannot satisfy. Existing mines date predominantly from the mid-20th century, with operations beginning between 1906 and 1982. These aging facilities operate at depths of 500-600 meters, often beneath lakes, requiring high operating costs and substantial capital expenditures. Regulatory challenges and thin historical margins have prevented new mine development despite growing demand from population growth, expanded road networks, and increased vehicle numbers.Atlas Salt's competitive advantage stems from its shallow 200-meter deposit depth, which allows access via horizontal drift rather than expensive vertical shaft construction. Located just three kilometers from an existing port facility, the project gains direct access to Atlantic Ocean shipping lanes and the eastern seaboard market. The simplified production process requires only mechanical crushing of 96% grade salt—no chemical processing, tailings, or refining—enabling two-month environmental assessment approval.At full production capacity of 4 million tons annually, Atlas would need to capture only 30-40% of current import volumes, targeting non-cyclical government customers legally mandated to purchase salt for road safety. The market's inelastic demand was demonstrated in January 2026 when Ontario spot prices surged from $65-75 per ton to over $190 during severe winter conditions. CEO Nolan Peterson emphasizes the dual investment appeal: "We are working with lenders who view this as investing into an airport or power plant—something that has long-term sales baked in because you're selling your product to governments, citizens and people."View Atlas Salt's company profile: https://www.cruxinvestor.com/companies/atlas-saltSign up for Crux Investor: https://cruxinvestor.com

Part 2 of a 2-part episode on Information Blocking From a December 2025 WEDI virtual spotlight, a panel of health IT leaders break down the current state and the future of regarding information blocking, and how organizations can stay compliant while moving interoperability forward. The panel: Rebekah Fiehn, Strategic Partnership Developer, American Dental Association Andrew Tomlinson, Senior Director, Regulatory & International Affairs, AHIMA Arna Meyer, Technical Product Manager, Stedi Alisa Kuehn, VP, General Counsel & Privacy Officer, Indiana Health Information Exchange Chelsea Arnone, Director, Federal Affairs, CHIME Sasha TerMaat, EHRA's Information Blocking Compliance Task Force The moderator is Jeff Coughlin, Director, Federal Affairs, American Medical Association

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of significant shifts in the industry, marked by leadership changes, scientific advancements, strategic partnerships, and regulatory challenges.Starting with Sanofi, a notable leadership transition has taken place as Paul Hudson steps down from his role as CEO. Belen Garijo from Merck KGaA has stepped into this pivotal role. Her appointment is part of a broader industry trend toward diversifying leadership, especially with more women leading top-tier pharmaceutical companies. The implications of this shift could be profound for Sanofi, potentially stabilizing its operations and revitalizing its research pipeline. Stakeholders are keenly observing how this new leadership might steer Sanofi through complex market dynamics.In regulatory news, Moderna has encountered a significant hurdle with the FDA declining to review its next-generation mRNA flu vaccine. This decision has sparked an ongoing public dialogue between Moderna and U.S. health regulators, underscoring the complexities involved in navigating regulatory pathways for novel mRNA technologies beyond their initial success with COVID-19 vaccines. The Department of Health and Human Services has supported the FDA's decision, emphasizing the critical importance of meticulous scrutiny when it comes to new vaccine platforms. This development highlights the challenges biotech companies face in ensuring compliance with stringent regulatory standards.Financial updates reveal CSL experiencing a sharp decline in net profits, dropping from $2 billion to $384 million year-over-year. This financial downturn has been linked to strategic missteps or operational inefficiencies within the company, prompting a change in leadership. Such shifts reflect broader challenges faced by companies within the biotech sector as they strive to maintain financial stability amid fluctuating market conditions.In contrast, Alnylam Pharmaceuticals has reported its first profitable year despite underwhelming sales figures for its drug Amvuttra in the ATTR-CM market. This milestone is significant for Alnylam as it demonstrates resilience and the potential to pivot successfully amidst market uncertainties. However, the company will need to remain vigilant about revenue streams and market dynamics moving forward.Turning to advertising strategies, Johnson & Johnson's Tremfya continues to buck industry trends by maintaining a strong presence in television advertising through 2026. This strategy is noteworthy given the general decline in traditional media spending across the industry. J&J's commitment highlights its determination to sustain market share against competitors such as AbbVie's Rinvoq and Skyrizi.On the strategic front, Takeda Pharmaceuticals is consolidating its U.S. operations by reducing its Boston presence. By subleasing over 630,000 square feet of office space, Takeda aims to streamline operations and concentrate resources on key development projects at its new Cambridge hub. This move reflects broader industry trends towards operational efficiency and resource optimization.In clinical advancements, BridgeBio has reached a promising milestone with successful Phase 3 trial results for infigratinib in treating dwarfism. This breakthrough offers new therapeutic options for children affected by this condition and exemplifies ongoing innovations in genetic medicine. The success of this trial positions BridgeBio on a path toward regulatory approval, potentially transforming care for patients with limited treatment options.Agilent has achieved FDA approval for its companion diagnostic test alongside Merck's Keytruda for ovarian cancer treatment. This approval highlights the growing importance of precision medicine in oncology, where tailored treatments based on individual paSupport the show

Guest: Bob Zimmerman. Musk announces SpaceX will prioritize the Moon before Mars; regulatory approvals for Starship launches are pending, while Voyager Space secures a management contract for ISS operations.1906. WELLS. MARTIAN

In this episode of the Rational Reminder Podcast, we are joined by Theresa Ebden, Vice President of the Investor Office at the Ontario Securities Commission, for a deep dive into how regulators are thinking about modern investor risks—from AI-powered scams to finfluencers and the gamification of investing apps. Theresa explains how the OSC works to protect investors through policy, education, behavioral research, and direct engagement with the public, and why investor education is one of the most powerful tools regulators have. Key Points From This Episode: (0:01:55) Overview of the OSC and why its investor research and education work matters. (5:42) What the Ontario Securities Commission does and its mandate to protect investors and capital markets. (6:25) Inside the OSC Investor Office: policy, education and outreach, and the investor contact centre. (9:28) How the Investor Office identifies priority issues using inquiry data, behavioral insights, and global collaboration. (12:11) The nature of investor inquiries: fraud, crypto confusion, complaints, and recovery room scams. (14:01) How contact-centre data feeds into education, outreach, and policy responses. (16:07) Overview of GetSmarterAboutMoney.ca and its role in investor education. (20:43) Major retail investor risks today: AI-enhanced scams, finfluencers, dark patterns, and gamification. (24:43) What to do if you're impersonated by AI in scam advertisements. (29:28) What a "finfluencer" is and the different categories they fall into. (31:01) Research findings on how strongly finfluencers influence investor decisions. (32:55) Why non-investors are especially vulnerable to finfluencer advice and social-media scams. (36:11) How investors can evaluate online financial advice and check credentials. (38:02) Regulatory challenges in overseeing finfluencers and online financial content. (41:04) How AI magnifies traditional scams and why AI-enhanced fraud is more effective. (43:42) Mitigation strategies: education, just-in-time warnings, and system-level tools. (47:25) Relationship investment scams and why they are especially damaging. (52:53) Research on gamification in investing apps and its effects on investor behavior. (55:25) The Get Smarter About Trading simulator and how it demonstrates gamification effects. (57:19) How gamification can be used positively to improve diversification and outcomes. (58:16) Theresa's perspective on success and her focus on improving the individual investor experience. Links From Today's Episode: Meet with PWL Capital: https://calendly.com/d/3vm-t2j-h3p Rational Reminder on iTunes — https://itunes.apple.com/ca/podcast/the-rational-reminder-podcast/id1426530582. Rational Reminder on Instagram — https://www.instagram.com/rationalreminder/ Rational Reminder on YouTube — https://www.youtube.com/channel/ Benjamin Felix — https://pwlcapital.com/our-team/ Benjamin on X — https://x.com/benjaminwfelix Benjamin on LinkedIn — https://www.linkedin.com/in/benjaminwfelix/ Dan Bortolotti — https://pwlcapital.com/our-team/ Dan Bortolotti on LinkedIn — https://ca.linkedin.com/in/dan-bortolotti-8a482310 Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com)

What do most people regret at the end of their careers? According to legendary venture capitalist Bill Gurley, it's not the failures — it's the risks they never took. In this wide-ranging episode of The Puck, Jim Baer sits down with Gurley — longtime Benchmark partner, early Uber board member, and author of Running Down a Dream — for a candid conversation on boldness, bubbles, AI speculation, venture capital cycles, and America's structural challenges. Gurley reflects on: - Why “boldness regret” weighs heavier than failure - How to turn passion into mastery — and why most people don't - The resume arms race and why young people feel trapped - AI: real revolution or speculative excess? (Hint: both) - Venture capital's evolution — from discipline to burn-at-all-costs - Why five-year AI forecasts may set companies up to stumble - Regulatory capture in healthcare and education - State-by-state competition as America's hidden advantage From Austin's music scene to Silicon Valley's capital cycles, Gurley delivers battle-tested insights from decades at the center of tech's biggest waves. If you care about careers, markets, AI, or the future of the U.S. economy, this episode is essential listening.

What does it take to deploy AI across national health systems? In Part 2, Vidur Mahajan shares lessons from large-scale rollouts at RadNet and Singapore's health network, covering interoperability, regulation, and success metrics.   Timestamps:  00:00 – Introduction  00:55 – Deploying CARPL  05:50 – Real-world stories  10:52 – Regulatory challenges  13:30 – Interoperability  16:17 – Success metrics 

In this crossover episode of The Consumer Finance Podcast and Payments Pros, Taylor Gess, Jason Cover, and Caleb Rosenberg explore the heightened attention from regulators and legislators on small business finance programs and trade credit. They discuss the growth of fintech-driven and embedded business-to-business financing, the shift from simple trade credit to more complex installment and term products, and how these offerings increasingly trigger disclosure, registration, rate cap, and fair lending requirements — sometimes even pulling in federal rules like Reg E and Reg B when consumer accounts are involved. This episode also emphasizes the expanding structure of state commercial financing laws in California, Texas, and other states, with a focus on new disclosure regimes, and novel consumer-type protections. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

When it comes to Data Center development, how much control should the state, county and municipal governments have?

SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards -  Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026  High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial 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 powered by Podcastics, the easiest platform to create and publish your podcast.

In this episode of Valley of Depth, we sit down with David Tearse, co-founder and CEO of Karman Industries, to explore a piece of the AI boom that rarely gets attention: thermal infrastructure.As hyperscale data centers grow into multi-gigawatt “AI factories,” the limiting factor is no longer just chips or capital — it's how efficiently we can move and reject heat. David explains how Karman's Heat Processing Unit (HPU) reimagines cooling from first principles, bringing aerospace-grade turbomachinery and modern power electronics to a decidedly unglamorous but critical layer of the AI stack.The conversation moves from the physics of heat to the politics of data centers, and ultimately to why thermal efficiency may become a quiet national security advantage.We discuss:Why thermal management—not chips—may be the next bottleneck in the AI stackHow Karman's HPU replaces traditional chillers and dry coolers outside the data centerHow much additional compute Karman can unlock from the same power inputWhy CO₂ refrigerant de-risks data center builds from a regulatory standpointHow Karman thinks about reliability, uptime, and “aerospace-style” engineeringWhy data centers are becoming a national security issueWhere Karman could expand beyond data centers—nuclear, geothermal, and beyond…and much more.• Chapters •00:00 – Intro00:51 – Elara Nova ad01:21 – Karman Industries mascot02:28 – How would David describe himself?05:01 – The original insight that became Karman Industries06:31 – What do people underestimate about thermal management?07:26 – The story behind the name08:21 – How David and co-founder CJ Karla ended up working together11:15 – Why is now the right time to be solving thermal management?15:13 – Where does the heat go today?16:31 – Energy usage for compute vs cooling17:32 – Energy Savings with Karman's heat processing units (HPUs)18:05 – Why C02?20:48 – Replacing vs integration21:37 – Regulatory side24:42 – Karman's customer pipeline26:33 – Reliability28:59 – Engineering challenges30:39 – What comes next for Karman31:55 – Is thermal management a national security issue?33:21 – David's thoughts on rerouting heat36:23 – HPUs in space37:58 – The company culture that allows for building relaiable solutions quickly44:35 – Milestones for Karman in the next couple of years47:00 – What does David do for fun? • Show notes •Karman's website —https://www.karmanindustries.com/David's socials — https://x.com/7earseMo's socials — https://x.com/itsmoislamPayload's socials — https://twitter.com/payloadspace / https://www.linkedin.com/company/payloadspaceIgnition's socials — https://twitter.com/ignitionnuclear / https://www.linkedin.com/company/ignition-nuclear/Tectonic's socials  — https://twitter.com/tectonicdefense / https://www.linkedin.com/company/tectonicdefense/Valley of Depth archive — Listen: https://pod.payloadspace.com/ • About us •Valley of Depth is a podcast about the technologies that matter — and the people building them. Brought to you by Arkaea Media, the team behind Payload (space), Ignition (nuclear energy), and Tectonic (defense tech), this show goes beyond headlines and hype. We talk to founders, investors, government officials, and military leaders shaping the future of national security and deep tech. From breakthrough science to strategic policy, we dive into the high-stakes decisions behind the world's hardest technologies.Payload: www.payloadspace.comTectonic: www.tectonicdefense.comIgnition: www.ignition-news.com

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's episode, we delve into the dynamic landscape of these industries, exploring ambitious strategic plans, regulatory hurdles, scientific breakthroughs, and emerging trends that are shaping the future of healthcare.Let's begin with AstraZeneca, which has set an ambitious target to achieve $80 billion in revenue by 2030. This goal reflects their intention to bring over 25 blockbuster drugs to market, underscoring a commitment to innovation and expansion in their therapeutic portfolio. The focus on cutting-edge research is not just a strategy for growth but also a sign of the broader industry trend where large pharmaceutical companies pursue high-value targets to strengthen their market positions. AstraZeneca is also making strides in the weight-loss market with its new candidate elecoglipron, undergoing an extensive late-stage program to evaluate its efficacy as a monotherapy and in combination treatments for various indications. This development positions AstraZeneca competitively in the burgeoning sector, offering a novel therapeutic option for obesity management.Meanwhile, CSL Limited is undergoing a leadership transition. CEO Paul McKenzie has stepped down under pressure, and Gordon Naylor has been appointed as interim chief. This change highlights the critical role of strategic leadership in navigating industry challenges and maintaining growth trajectories amidst a rapidly shifting market landscape.In a display of financial success, Novartis reported a record-breaking performance for 2025. This achievement led to a 30% increase in CEO Vas Narasimhan's compensation, reaching $32 million. The company's robust financial health is attributed to advancing innovative treatments targeting unmet medical needs, emphasizing how achieving innovation milestones can significantly enhance corporate valuation and leadership rewards.Incyte is preparing for the patent expiration of its blood cancer drug Jakafi in 2028 by focusing on Opzelura, a topical cream that has witnessed a 33% sales increase from the previous year. With sales reaching $678 million, Opzelura's success highlights Incyte's strategic pivot to diversify its product offerings and mitigate risks associated with patent cliffs. This exemplifies how companies must continuously innovate and adapt to maintain competitive advantages.Moderna has entered into a long-term agreement with Mexico to ensure local mRNA vaccine supply through technology transfer to Laboratorios Liomont. This partnership extends Moderna's global footprint and underscores the critical role of mRNA technology in pandemic preparedness and vaccine accessibility, reinforcing its transformative impact on public health strategies.Regulatory landscapes have also seen notable activity. The FDA issued untitled letters concerning potentially misleading drug advertisements from companies like Novo Nordisk, Argenx, and Sobi. Such actions emphasize regulatory vigilance in marketing practices. Additionally, Lilly's Kinsunla failed to secure approval in Scotland, while Regenxbio faced rejection for its gene therapy for Hunter syndrome. These regulatory hurdles highlight the rigorous oversight pharma companies face and the complex pathways drugs must navigate before market approval.Collaborations within the industry are proving crucial for innovation. Merck's collaboration with Calla Lily Clinical Care aims to enhance delivery systems for vaginal therapeutics. Similarly, Bristol Myers Squibb's partnership with Evinova focuses on integrating AI into clinical development processes. These alliances reflect an industry-wide emphasis on leveraging technology to improve drug delivery efficiency and streamline clinical trial operations.Shifting our focus now to scientific advancements and clinical trial results that aSupport the show

In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.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 Justin Zenanko.

What if the solution to healthcare's coding workforce challenges has been hiding in plain sight?The conversation doesn't end with rethinking who can succeed in medical coding. In Part II of this special Talk Ten Tuesday series, the focus is on how healthcare organizations can get involved.This broadcast will highlight a growing partnership with the American Health Information Management Association (AHIMA), and outlines how organizations can participate in a neurodiversity-focused coding internship model.Learn what it means to host interns, support neurodiverse candidates, and create structured, sustainable pathways into health information management (HIM) careers.For healthcare leaders facing persistent workforce shortages, accuracy concerns, and burnout, this discussion will move from inspiration to implementation – showing how inclusive workforce strategies can strengthen coding operations while expanding opportunities.If you're ready to move beyond awareness and explore practical ways to build a more resilient, forward-thinking coding workforce, this is for you.The popular Internet broadcast will also feature these additional instantly recognizable panelists, who will report more news during their segments:POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of Davis Medical Center, will share her point of view during the broadcast.CDI Report: Cheryl Ericson will provide an update on clinical documentation integrity (CDI).The Coding Report: Christine Geiger will report on the latest coding news.News Desk: Timothy Powell, ICD10monitor national correspondent, will anchor the Talk Ten Tuesdays News Desk.

Cybersecurity is no longer just an IT or privacy issue. For FDA regulated companies, it's a patient safety issue, a product quality issue, and increasingly a regulatory enforcement issue. FDA has made it clear that cybersecurity vulnerabilities can affect medical devices, software, manufacturing operations, clinical data, and even the availability of life saving products.Today, we're bringing together two perspectives—the FDA regulatory lens and the cybersecurity lens—to talk about what companies need to understand and where they're getting tripped up.Questions and Comments: wkirton@bakerlaw.com or egyasi@bakerlaw.com

Welcome to the 9Innings Podcast where we Educate, Empower and Engage. ON THIS WEEKS PODCAST: In this episode of the 9innings Podcast," host Kevin Thompson and guest Tyrone Ross Jr. analyze the recent turmoil in Bitcoin and the broader crypto market. They discuss causes of the downturn, institutional involvement, regulatory uncertainty, and the shift toward permissioned blockchains. Tyrone critiques the dilution of crypto's original vision, warns of speculative risks, and calls for a market “washout” to eliminate weak projects. The conversation covers blockchain transparency, misconceptions about Bitcoin ownership, and the future of digital assets, emphasizing the need for education, better infrastructure, and a more sustainable crypto ecosystem. Recent Bitcoin Liquidations and Market Downturn (00:01:28) Institutional Involvement and Co-opting of Crypto (00:03:50) Crypto's Original Sins and Market Narratives (00:06:47) Altcoins, Scams, and Market Washout (00:08:11) Problems with Crypto Trading and Market Structure (00:11:43) Regulatory and Custody Challenges (00:14:53) Venture Capital, Founders, and Retail Burnout (00:17:36) Blockchain Transparency and Traceability (00:22:16) Long-Term Vision for Crypto and Blockchain (00:25:27) High Interest Rates in Crypto and DeFi Risks (00:28:36) NEWSLETTER (WHAT NOW): https://substack.com/@9icapital?r=2eig6s&utm_campaign=profile&utm_medium=profile-page Follow Us: youtube: / @9icap Linkedin: / kevin-thompson-ricp%c2%ae-cfp%c2%ae-74964428 facebook: / mlb2cfp Buy MLB2CFP Here: https://www.amazon.com/MLB-CFP%C2%AE-90-Feet-Counting-ebook/dp/B0BLJPYNS4 Website: http://www.9icapitalgroup.com Hit the subscribe button to get new content notifications. Corrections: Editing by http://SwoleNerdProductions.com Disclosure: https://sites.google.com/view/9idisclosure/disclosure

It's raining RACs.The Recovery Auditor Contractors (RACs), together with an alphabet soup of other private and public auditors, are coming down hard on hospitals and physician practices, looking for omissions and errors in submitted claims.Then there are seemingly contradictory rules from the Centers for Medicare & Medicaid Services (CMS).It's little wonder that providers are treading cautiously as they look to thread the needle of compliance.This coming Monday, the venerable Monitor Mondays broadcast will present a cadre of the sharpest minds in healthcare auditing. You'll hear auditing news you won't find anywhere else – just here.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.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a fascinating array of stories that highlight the scientific advancements, regulatory updates, and strategic maneuvers shaping our industry.Let's begin with Biogen's efforts to breathe new life into its spinal muscular atrophy treatment, Spinraza. In response to declining sales, Biogen is launching a high-dose version in Japan, aiming to enhance therapeutic efficacy and regain market competitiveness. This move underscores the company's strategy to offset projected revenue declines by 2026. The decision to pursue this high-dose version reflects Biogen's commitment to maintaining its foothold in a challenging market landscape where innovation is key to survival.Shifting gears to regulatory news, the FDA, led by Commissioner Marty Makary, has taken a firm stance against the proliferation of illegal copycat drugs. This announcement comes on the heels of Hims & Hers' controversial introduction of a compounded version of Novo Nordisk's obesity drug, Wegovy. The FDA's commitment to protecting intellectual property and patient safety is crucial in an era where health tech firms increasingly challenge traditional pharmaceutical boundaries. Novo Nordisk's aggressive marketing strategy for Wegovy, including a high-profile Super Bowl advertisement, highlights the competitive pressures in this growing market segment and underscores the legal tensions between established pharma giants and emerging tech-driven companies.In an unexpected turn of events, BridgeBio faced a significant setback as Pfizer withdrew its tafamidis patent in Europe. This led to a notable drop in BridgeBio's stock price and raised concerns about earlier generic entries into the ATTR-CM market. Such developments signal potential shifts in market dynamics and pricing strategies that companies must navigate carefully.On the clinical front, Bayer's phase 3 study of asundexian has demonstrated remarkable results—a 26% reduction in stroke risk. This positions Bayer favorably against competitors Bristol Myers Squibb and Johnson & Johnson, setting a new benchmark in the high-stakes anticoagulant market. Innovation continues to be paramount as companies strive for superior clinical outcomes that can significantly impact patient care.Regulatory landscapes are evolving as well, with Gilead's Yescarta receiving clearance for expanded use. These milestones are crucial for broadening therapeutic indications and enhancing patient access, underscoring ongoing efforts to address unmet medical needs while sustaining growth trajectories.Meanwhile, Pfizer-backed Priovant has reported promising mid-stage results for brepocitinib in treating dermatomyositis and other rare skin conditions. As a TYK2/JAK1 inhibitor, brepocitinib exemplifies precision medicine's expanding role in addressing autoimmune disorders through targeted therapies.The IPO scene remains vibrant with Agomab Therapeutics and Spyglass Pharma making substantial entries into Nasdaq, collectively raising $350 million. This influx indicates continued investor confidence in biopharma innovation despite broader economic uncertainties—a testament to the sector's resilience and potential for groundbreaking advancements.Corporate dynamics are also shifting as seen with Moderna's Chief Medical Officer Jacqueline Miller stepping down after a brief tenure. Leadership changes such as these often signal strategic realignments within companies as they adapt to complex regulatory environments and competitive pressures.Summarizing these developments illustrates a dynamic landscape marked by scientific innovation, regulatory vigilance, and strategic marketing initiatives. As companies strive for competitive advantage through new drug formulations and market expansions, they must also navigate legal challenges and regSupport the show

In this episode, Harsha Goli from Magnolia Financial discusses the launch of their Bitcoin-enabled banking services across the US, navigating regulatory challenges, and the importance of partnerships with banks. He emphasizes the need for better user experiences in Bitcoin transactions, the role of price oracles, and the implications of the Clarity Act on Bitcoin development. The conversation also touches on the tension between traditional banks and the crypto industry, the future of community banks, and innovations in Bitcoin technology. Harsha shares insights on potential use cases for Magnolia's services and the challenges of bridging the gap in Bitcoin adoption, while also addressing privacy concerns in Bitcoin transactions.Takeaways:

In this Editor's Special Episode of The HemOncPulse, a conversation with Nicholas Richardson, DO, MPH, vice president of clinical development at Precision for Medicine, focuses on the evolving regulatory role of measurable residual disease in multiple myeloma clinical trials. The discussion is designed to contextualize recent FDA draft guidance for a broad clinical and research audience.

Who determines what 'good' Compliance actually looks like?  The obvious answer is regulators (and in some jurisdictions) prosecutors. But what if it were the regulated Firms themselves?  That's the idea behind purpose-driven compliance, which I'm exploring on this episode.Episode Summary To explore this, I'm joined by Veronica Root Martinez, Professor of Law at Duke University School of Law, to explore a deceptively simple but unsettling idea: 100% compliance is impossible. While we often behave as though perfect compliance is the goal — and in some safety-critical domains it must be — most organisational compliance involves humans. And humans make mistakes. Things get missed. Context changes. Stuff goes wrong.So if perfection isn't realistic, the real question becomes: how do organisations decide what really matters? The traditional answer has been to look outward — to regulators, enforcement authorities, and in some jurisdictions (particularly the US), prosecutors. Their priorities, expressed through sentencing guidelines, enforcement actions, and settlements, end up defining what “good” compliance looks like. Veronica challenges that logic. She argues that this gets things the wrong way round. Instead of letting enforcement priorities dictate behaviour, she makes the case for purpose-driven compliance — where organisations set their own priorities based on their purpose, values, and actual risks, rather than chasing shifting regulatory expectations. Along the way, the conversation explores culture, human judgment, psychological safety, technology, experimentation, and why “best practice” can sometimes make things worse rather than better. This episode is for anyone who writes rules, enforces them — or simply has to live under them.Guest BiographyVeronica Root Martinez is a Professor of Law at Duke University School of Law, where she researches corporate compliance, ethics, and organisational culture. Her work on purpose-driven compliance challenges enforcement-led models and explores how organisations can set priorities based on their own purpose, values, and risks.Before entering academia, Veronica practised as an associate at a large law firm in Washington, DC, where she worked on regulatory and white-collar matters — experience that strongly informs the practical orientation of her research.LinksProfessor Veronica Root Martinez – Faculty Profilehttps://law.duke.edu/fac/martinezVeronica on LinkedInhttps://www.linkedin.com/in/veronica-root-martinez/Purpose-Driven Compliance (paper discussed in the episode)https://papers.ssrn.com/sol3/papers.cfm?abstract_id=6078766AI-Generated Timestamped Summary00:00 – 02:00 | “Because they said so”Christian reframes compliance as a universal human experience — not just a professional discipline — and introduces the problem of rules justified solely by regulatory expectation.02:00 – 05:30 | Why 100% compliance is impossibleVeronica explains why modern organisations cannot realistically achieve perfect compliance when humans are involved — and why pretending otherwise creates problems.05:30 – 10:30 | Tolerated misconduct and cultural driftHow allowing “small” rule-breaking can escalate into bigger issues, drawing on behavioural ethics and real-world corporate failures. 10:30 – 14:30 | Risk, prioritisation, and what really mattersA discussion of risk-based thinking, irrecoverable vs recoverable errors, and why organisations — not regulators — are best placed to set priorities. 14:30 – 18:30 | Enforcement swings and resilienceWhy compliance programmes built around enforcement trends are fragile, expensive, and reactive — and how purpose-driven approaches create stability. 18:30 – 23:30 | Innovation, uncertainty, and guardrailsWhy regulators are always behind innovation — and how values-based guardrails help employees make decisions in uncharted territory.23:30 – 30:30 | Technology, AI, and the human in the loopThe limits of automation, the danger of over-reliance on tech, and why human judgment remains essential.30:30 – 36:30 | Rules, loopholes, and malicious complianceHow overly detailed rulebooks create loopholes — and why purpose and principles offer a better basis for accountability.36:30 – 40:30 | The Costco exampleA powerful illustration of simplicity: four ethical principles that employees can actually understand and use.40:30 – 45:30 | Training, regulators, and unintended consequencesWhy blanket training requirements often miss the mark — and how enforcement agreements can accidentally undermine effectiveness.45:30 – 52:30 | Measuring culture and compliance effectivenessMoving beyond counting inputs to assessing outputs, including psychological safety, Speak Up systems, and cultural indicators.52:30 – 57:30 | Experimentation and learningWhy failed interventions aren't failure — they're information — and why compliance should be treated as an evolving experiment.57:30 – End | Reclaiming responsibilityA closing reflection on extrinsic motivation, “because I said so,” and why purpose-driven compliance offers a more human, defensible, and sustainable way forward.

Send us a textBob Hankins brings over 20 years of dedicated experience in the medical-device industry, spanning engineering leadership, product development, process improvement and strategic technical oversight. As Director of Engineering at TE Connectivity, he leads a global team of engineers and scientists focused on designing, developing and delivering innovative customer-centric medical device solutions—particularly complex machined, extruded and laser-cut components. In this role he ensures design for manufacturing and quality within ISO 13485-compliant systems, marrying deep technical understanding with regulatory-driven manufacturing discipline.Before his current role Bob led Research & Product Development Engineering at Nordson Medical and has held key leadership positions at several medical-device companies, including overseeing product development platforms, multi-site engineering operations, manufacturing automation and system launches. Throughout his career he has honed core competencies in manufacturing process improvement, continuous improvement (including Six Sigma/Lean methodologies), design for manufacturing/assembly, regulatory compliance (ISO 13485, ISO 14971, FDA), and product R&D for the health-care market.Bob's academic background includes a Bachelor of Science in Mechanical Engineering from the University of California, Irvine, and an Executive MBA from the Drucker School at Claremont Graduate University. This combination of technical and business education supports his ability to lead engineering organizations in bridging innovation with operational execution, customer development and quality.In this episode we'll dive into how Bob thinks about leading engineering teams in the regulated medical-device space, how he drives design and process improvements globally, how he balances innovation with manufacturing rigor, and what advice he has for engineers growing into leadership roles in healthcare technology. We'll also explore his views on what the next wave of medical-device manufacturing and design looks like—and how engineering leaders can foster a culture of excellence, empowerment and impact. LINKS:Guest LinkedIn: https://www.linkedin.com/in/rthankins/Guest website: https://www.te.com/en/home.html Aaron Moncur, hostThe Wave is  a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.engineer Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus

Welcome back to the markets after a brutal weekend. Gold just had its worst day since 1983, crashing 9%, while silver fell a staggering 27%—the largest drop ever recorded. Add to that steep declines in copper and oil, and we've got the recipe for a volatile open. Meanwhile, Asian equities got crushed, with the KOSPI down 5%, and China's manufacturing PMI missed badly. In Europe, green shoots: France and the UK posted surprise PMI gains, while Germany's retail sales shocked to the upside. In crypto, BTC fell to $74K before rebounding, with more than $5.5B in liquidations since Thursday. Regulatory talks begin today at the White House, while Ripple secures a full EU license. The week is off to a chaotic start—catch the full breakdown inside.