Podcasts about clinical data

In this episode of Clinical Conversations, Dr Emma Spencer discusses the importance of digital health literacy - the ability to access, understand and use digital health tools - with Professor Mahmood Adil, RCPE's outgoing Clinical Data & Digital Health Lead. Prof Adil provides insights into the evolution of digital health and clinical informatics over his career and how doctors can enhance their digital health literacy. The introductory resource on clinical data and digital health can be accessed on RCPE's Education Portal: https://learning.rcpe.ac.uk/data-digitalhealth Professor Mahmood Adil was RCPE's Clinical Data & Digital Health Lead. He is a global expert in clinical data, digital health & innovation fields. He has over 25 years of medical, public health, executive management, academic and policy experience and has delivered on key senior positions in the UK, USA & Middle East. Dr Emma Spencer is Co-Vice Chair - Education of RCPE's Trainees and Members' Committee and resident doctor in internal medicine. RCPE would like to thank Professor Adil for his contributions and service as our Clinical Data & Digital Health Lead. Recording date: 17 April 2026 An extended version of this episode will be released on our sister podcast, Career Conversations, later this year: https://podcasts.rcpe.ac.uk/show/career-conversations/ -- Follow us -- https://www.instagram.com/rcpedintrainees -- Upcoming RCPE events -- https://www.rcpe.ac.uk/events -- Become an RCPE Member -- https://www.rcpe.ac.uk/membership/join-college Feedback: cme@rcpe.ac.uk This podcast is from the Trainees & Members' Committee (T&MC) of the Royal College of Physicians of Edinburgh (RCPE).

Great science doesn't always translate into a scalable product, and that gap can stall even the most promising innovations. In this Mol Bio Minutes episode, Steve Lewis explores a common challenge in biotech: moving from a validated assay or prototype to a commercially viable product. While scientific teams often achieve strong early results, scaling requires coordination across design, engineering, materials, and manufacturing, which typically involves multiple vendors. This fragmented process introduces delays, misalignment, and risk. The episode highlights how physical product design, especially for consumables like microfluidic cartridges or custom plastics, can ultimately determine whether a solution reaches the market. By integrating design, prototyping, and manufacturing under one roof, Thermo Fisher Scientific's Plastics Prototyping Services aim to streamline this transition. Early consideration of materials, manufacturability, and reagent compatibility enables faster iteration and more efficient scale-up, particularly for startups navigating growth stages. Ultimately, the message is clear: if your biology works but your product doesn't scale, the problem is solvable. With the right integrated approach, innovation doesn't have to stall, it can move efficiently from idea to impact. Helpful resources and links: Learn more about Thermo Fisher Plastics Prototyping Services Access information about reagents and raw materials for use in your product(s) Subscribe to get future episodes as they drop and if you like what you're hearing we hope you'll share a review or recommend the series to a colleague.  Visit the Invitrogen School of Molecular Biology to access helpful molecular biology resources and educational content, and please share this resource with anyone you know working in molecular biology. For Research Use Only. Not for use in diagnostic procedures.

BiTEs or bispecific T-cell engager antibodies are an emerging class of therapies with significant potential to advance cancer treatment. Pharmacists will play a key role both in the utilization of these agents but also in the mitigation and management of the unique toxicities that accompany them. This podcast provides insights into the patient care needs and novel interdisciplinary models employed to support patients receiving BiTE therapies. Listeners will gain key insights into BiTE therapies, including their role in treatment, the current pipeline, and safety considerations. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

Greg Miller, VP of Marketing and Business Development at Carta Healthcare,  is focused on the multi-billion-dollar problem of manual clinical data abstraction in health systems, which is time-consuming, labor-intensive, and error-prone. The Carta hybrid intelligence solution combines AI  with human expertise to surface and validate information, delivering dramatic ROI for clients through lower costs and higher data quality. Clinician adoption grows significantly once they have experienced the AI finding information they would have missed, ultimately making them more effective at their jobs. Greg explains, "Health systems in the US, specifically, spend between $10 and $15 billion a year on manually abstracting data. And what are they abstracting data for? "There are lots of different downstream use cases, but the most common reason is to populate clinical registries. And clinical registries are super important because they're used for accreditation of clinical programs. It's for revenue, it's for compliance and regulatory requirements. But the biggest use of registry data is to drive quality and process improvement initiatives." "Unfortunately, today, every hospital has an abstraction function that is highly decentralized, and they have highly skilled labor, mostly nurses, who manually come through the electronic health record and other systems to find nuggets of information to answer questions in some registry system. And so it's very time-consuming, labor-intensive, and, because it involves humans, both expensive and prone to error."  #CartaHealthcare #HealthcareAI #HybridIntelligence #ClinicalAI #HealthTech #DigitalHealth #AIinHealthcare #LifeSciences #HealthData #AIgovernance #ResponsibleAI #ClinicalInnovation #HealthcareLeadership #HealthcareInnovation #ClinicalData #QualityImprovement #PatientSafety #DataAbstraction #HybridIntelligence carta.healthcare Download the transcript here

Greg Miller, VP of Marketing and Business Development at Carta Healthcare,  is focused on the multi-billion-dollar problem of manual clinical data abstraction in health systems, which is time-consuming, labor-intensive, and error-prone. The Carta hybrid intelligence solution combines AI  with human expertise to surface and validate information, delivering dramatic ROI for clients through lower costs and higher data quality. Clinician adoption grows significantly once they have experienced the AI finding information they would have missed, ultimately making them more effective at their jobs. Greg explains, "Health systems in the US, specifically, spend between $10 and $15 billion a year on manually abstracting data. And what are they abstracting data for? "There are lots of different downstream use cases, but the most common reason is to populate clinical registries. And clinical registries are super important because they're used for accreditation of clinical programs. It's for revenue, it's for compliance and regulatory requirements. But the biggest use of registry data is to drive quality and process improvement initiatives." "Unfortunately, today, every hospital has an abstraction function that is highly decentralized, and they have highly skilled labor, mostly nurses, who manually come through the electronic health record and other systems to find nuggets of information to answer questions in some registry system. And so it's very time-consuming, labor-intensive, and, because it involves humans, both expensive and prone to error."  #CartaHealthcare #HealthcareAI #HybridIntelligence #ClinicalAI #HealthTech #DigitalHealth #AIinHealthcare #LifeSciences #HealthData #AIgovernance #ResponsibleAI #ClinicalInnovation #HealthcareLeadership #HealthcareInnovation #ClinicalData #QualityImprovement #PatientSafety #DataAbstraction #HybridIntelligence carta.healthcare Listen to the podcast here

Marco Quarta is co-founder and Chief Scientific Officer of Rubedo Life Sciences, a precision-therapeutics company developing medicines that target the pathological cell states that drive age-associated disease. Marco's first appearance on the show was three years ago, in February 2023 (Episode 35), when Rubedo was a much earlier-stage company committed to the then-contrarian premise that "the senescent cell" is not a single entity but a heterogeneous family of cell states that needs to be deconvoluted at the single-cell level. In March 2026, Rubedo reported preliminary Phase 1b/2a clinical data for its lead candidate, RLS-1496, a first-in-class topical GPX4 modulator. Marco returns to the show to discuss what survived contact with human biology.In this episode, Chris and Marco unpack the readout from Rubedo's basket trial across four skin indications — psoriasis, atopic dermatitis, actinic keratosis, and photoaged skin — and the biology that underlies it. RLS-1496 came clean on safety in all four indications, with significant efficacy signals despite small patient numbers and short (20–30 day) treatment courses. More provocatively, the clinical and translational data have pushed Marco to redefine what kind of drug this actually is. Rather than a next-generation senolytic, GPX4 modulation appears to act as a state-gating intervention: it triggers ferroptosis in deeply senescent cells that have already crossed a redox threshold, while inducing a hormetic "redox reset" in stressed-but-recoverable cells that restores them to a healthier state. Marco proposes a new category to capture this dual action — adaptive senotherapeutics, or senoadaptive drugs — distinct from senolytics and senomorphics.The conversation traces the arc from Rubedo's founding thesis to a clinically validated platform (ALEMBIC, the AI-enabled single-cell multiomics engine that surfaced GPX4 as a target), through the strategic logic of leading with skin, into the broader question every longevity-biotech founder eventually has to answer: when does a disease-by-disease franchise become a credible preventive geroscience platform? Marco lays out the GLP-1 analogy explicitly — an anchor indication and a label-expansion roadmap that could carry GPX4 modulation from dermatology into respiratory, neurodegenerative, and metabolic disease, and ultimately into the use case where biomarkers of cellular senescence flag patients for therapy decades before disease becomes clinically apparent.The Finer Details:How Marco's 2023 contrarian view — that "senescent cells" hide a tissue- and state-specific reality — has been reinforced by the clinic, and how Rubedo's framing has shifted from "targeting senescent cells" to "targeting pathological cell states"The biology of GPX4 as a lipid-peroxidation gatekeeper, why senescent cells have intrinsic vulnerabilities (p16, p21, CDK4/6 inhibition) that make them ferroptosis-sensitive, and how Rubedo's approach differs from oncology-focused GPX4 programs at Takeda and othersThe "senoadaptive" mechanism — RLS-1496 eliminates GPX4-dependent senescent cells via ferroptosis while triggering NRF2/Keap1-driven redox reset, autophagy, and epigenetic remodeling in recoverable cells, restoring tissue trajectory from degenerative to regenerativeWhy Rubedo led with skin: clean regulatory path, accessible tissue, the ability to read out aging biology anddisease in the same trial, and a label-expansion runway into systemic indicationsPhase 1b (Europe) and Phase 2a (US) basket-trial results across psoriasis, atopic dermatitis, photoaged skin, and actinic keratosis: clean safety in 4/4 indications and significant efficacy signals — itch reduction in atopic dermatitis, decreased lesional thickness in psoriasis, target-engagement-correlated clinical improvement in photoaged skinThe richness of the translational dataset: biopsies, tape-stripping, spatial transcriptomics, proteomics, multiplex histomics, plasma biomarkers — all feeding back into ALEMBIC to refine the platformWhy actinic keratosis is the most strategically important indication — an age-related, chronic-inflammatory, precancerous condition where Rubedo can simultaneously test disease modification and biological-age reversalThe Rubedo–Beiersdorf partnership and the cosmetic vertical as a parallel commercial axisPipeline beyond skin: targeting aberrant basaloid stem cells in IPF and other pulmonary indications using different modalities (prodrugs, PROTACs, ADCs) to achieve cell-state selectivityThe longer-arc vision: senescence biomarkers as a "prediabetes-style" early signal, with senoadaptive drugs deployed decades before disease — and what a GLP-1-scale franchise might look like for GPX4 modulationQuotes:"There is not such a thing as a senescent cell — like there is not a cancer cell. And that was the initial idea. I'm glad that over time the field evolved. Now this is an accepted concept in the senotherapeutic space.""We are really talking about a dual function of RLS-1496 that can modulate the cell state depending on the adaptive response. That's why we call this — de facto — a new class of senotherapeutics. We call them adaptive senotherapeutics, or senoadaptive drugs — not a senolytic or a senomorphic, but working by modulating the cell state.""The best animal model for human therapies is human. As much as you can do preclinical work in animal models, it's always an approximation. We were able to test this directly in patients for safety, and in 4 out of 4 indications, we didn't have any safety signal.""Imagine you're taking care of a growing tree, and this tree has some dead leaves and some are a little bit stressed. If you shake the tree, the dead leaves will fall; the healthy leaves will not, because they're healthy and they resist the shake. But that shake actually gives the stressed leaves space and breathing room, and helps them to regain vitality. That's a little bit what GPX4 modulation does.""Senotherapeutics is a large, growing field — an untapped therapeutic opportunity. There is no such thing as a pan-senolytic or a pan-senotherapeutic, like there is no pan-oncotherapeutic. You need to understand the context. But these will all be part of the arsenal for true longevity medicine.""I don't see this as prevention of disease. The way I see therapies like ours, and the way the field of longevity is developing, is treating diseases decades before they develop. That's not a new concept — that's what we're doing in diabetes. You can be diagnosed with prediabetes today and reverse those biomarkers with lifestyle changes or metformin, and maybe never develop diabetes. That's exactly what we're doing here.""First of all, celebrating the first approved drugs from Rubedo — I don't think we're too far from that. But that's also a beginning, because you learn from the big momentum the GLP-1 agonists created: how a drug can start in one indication, create a new field, and prove that you can go beyond that. I hope in a few years we come back and talk about the next GLP-1 — this could be GPX4 modulators, or the senoadaptive drugs that are first in our pipeline."Links:Rubedo Life Sciences: https://www.rubedolife.comMarco Quarta's previous appearance on Translating Aging: Ep 35 — Targeting Pathologic Cells to Preserve Biological Youth

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In a rapidly evolving industry landscape, artificial intelligence has emerged as a game-changer, transforming how major pharmaceutical companies approach drug development and diagnostics. Roche's strategic acquisition of PathAI for over $1 billion exemplifies this shift, highlighting the growing importance of AI-driven diagnostics in digital pathology. This move signals a broader trend where AI is no longer just a theoretical concept but a practical tool enhancing healthcare delivery. Alnylam's recent challenges with its web-based presentation of Amvuttra data underscore the need for accuracy in representing clinical data digitally—showing that while AI can offer innovative ways to present data, it also demands rigorous standards to ensure clarity and prevent misleading claims. On the regulatory front, the FDA's evolving stance on cell therapy Ebvallo, alongside its new one-day assessment pilot program, is shaping the industry's regulatory environment. The reconsideration of Ebvallo's earlier rejection due to single-arm trial data concerns illustrates the FDA's willingness to adapt its regulatory framework to accommodate innovative therapies. This adjustment could potentially pave the way for other gene therapies in development, including those by UniQure. Moreover, Sanofi's withdrawal of Tzield from the FDA's contentious Commissioner's National Priority Voucher program reflects ongoing debates about expedited review processes, underscoring the need for transparent and efficient pathways for bringing new therapies to patients swiftly. Additionally, the FDA's AI-guided inspection pilot aims to modernize compliance strategies and enhance pharmaceutical manufacturing oversight. In clinical trials, companies continue to face both triumphs and setbacks. Entrada Therapeutics experienced a significant decline in stock value following underwhelming Duchenne Muscular Dystrophy trial results, potentially reshaping competitive dynamics in favor of rivals like Novartis. Conversely, Angelini Pharma is making strategic moves with its $4.1 billion acquisition of Catalyst Pharmaceuticals, targeting market expansion in the U.S. through Firdapse, which is poised to make significant impacts in treating rare diseases. MingMed Biotechnology's promising phase 2 results for QA102 could signal new treatment paradigms for dry AMD—a condition with limited current interventions. Therapeutic innovation is also being driven by policy shifts that encourage research into psychedelic drugs for mental health treatment. Optimi Health's IPO indicates growing investor interest in this area, fueled by regulatory easing under recent executive orders aimed at facilitating psychedelic research. Strategic pipeline adjustments are evident as companies realign their focus based on emerging data insights. Ascendis Pharma's decision to halt its IL-2 oncology program marks a shift toward more promising avenues, while Beone Medicines' restructuring reflects a similar strategy by discontinuing several early-stage cancer programs. The industry's dynamism is further illustrated by Eli Lilly's substantial $4.5 billion investment in expanding its Indiana campus. This move not only enhances Lilly's capacity for genetic medicine and metabolic disease manufacturing but also underscores a broader industry commitment to precision medicine and biologics—fields anticipated to play pivotal roles in future healthcare solutions. Meanwhile, Bayer's acquisition of Perfuse Therapeutics seeks to bolster its ophthalmology portfolio, addressing significant unmet needs in eye disease treatments. Novo Nordisk's success with Wegovy highlights strong market demand for effective obesity treatments, demonstrating an industry-wide shift towards addressing lifestyle-related diseases. LegislSupport the show

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with John Schindler, CEO of Liquet Medical, for a "MedTech Founder 101" masterclass. With over 25 years of experience at industry giants like Atrium and Merit Medical, Schindler shares the "painful reality checks" that come when transitioning from the structured umbrella of a large corporation to the high-stakes, resource-dependent world of a startup.The conversation dives deep into the philosophy of "novel but simple" technology. Schindler explains why simplicity is often harder to fund but essential for physician adoption and long-term market success. He challenges the current industry obsession with over-engineered solutions, arguing that the pendulum is swinging back toward intuitive, easy-to-use devices that don't "break the system" of healthcare delivery.Finally, the discussion covers the tactical realities of commercialization, including the nuances of the "Valley of Death." Schindler outlines why a limited market release is often superior to broad distribution and emphasizes the importance of building strategic enterprise value through intentional clinical data that speaks to both regulatory bodies and hospital value analysis committees.Key Timestamps00:45 – Introduction to John Schindler and Liquet Medical's mission.02:15 – The Corporate vs. Startup Reality: Losing the safety net of big-company resources.04:30 – Simplicity vs. Complexity: Why investors favor "shiny" tech but physicians crave simplicity.07:50 – The MedTech Innovator Experience: Leveraging human capital and "pressure testing" your company.10:15 – Unlearning Corporate Silos: The necessity of radical collaboration in early-stage teams.12:40 – Clinical Data Strategies: Moving beyond "clinical wins" to hospital value analysis.15:30 – Establishing "Soft Endpoints" for payers and rural healthcare settings.18:20 – Negotiating as a Cash-Strapped Startup: Approaching vendors and regulatory services with humility.21:10 – The Regulatory Chess Game: Why early engagement with the FDA prevents timeline resets.24:35 – Commercialization and the 510(k) vs. IDE strategy.27:15 – The Risks of Distribution Agreements: Why products "fall to the bottom of the bag."Quotes"The complexity can actually break the system in some ways. Physicians always gravitate back towards simplicity—things that are easy for them to wrap their heads around." - John SchindlerTakeawaysMaster the Holistic Approach: Founders should seek exposure to every facet of the business—sales, management, and business development—to understand how their innovation responds "in the trenches."Everything is Negotiable: Especially for cash-strapped startups, approaching regulatory and quality service providers with humility can lead to flexible contract structures that help build a strong foundation early.Clinical Data is for Post-Submission too: Don't just collect data to satisfy the FDA; identify "soft endpoints" that prove economic value to hospital value analysis committees and payers.Control Your Launch: A Limited Market Release (LMR) allows a startup to "get their nose bloodied" on a small scale, refining the sales methodology before attempting to scale nationally.Avoid the "Bottom of the Bag" Syndrome: Be cautious with large distribution agreements early on. If the sales force isn't properly incentivized or trained, your product may be ignored in favor of higher-margin legacy items.ReferencesMedTech Innovator: The world's largest accelerator for medical device companies.Hal Stowe (Eurofins): Referenced for his recent article on the strategic value of a purposeful regulatory strategy.Etienne Nichols: Connect with the host on LinkedIn.MedTech 101: The 510(k) vs. IDEIn this episode, John mentions having a 510(k) clearance but needing an IDE trial.510(k): Think of this as the "Me Too" pathway. You are telling the FDA your device is "substantially equivalent" to one already on the market. It gets you through the door, but often with limited claims (a "tool claim").IDE (Investigational Device Exemption): This allows your device to be used in a clinical study to collect safety and effectiveness data. It's like a "permit" to do the deep research needed to prove your device can treat a specific, high-stakes condition like a pulmonary embolism.SponsorsThis episode is brought to you by Greenlight Guru. For MedTech founders looking to avoid the regulatory headaches discussed today, Greenlight Guru offers the only dedicated Medical Device Success Platform. From their industry-leading QMS (Quality Management System) to their robust EDC (Electronic Data Capture) solutions, they help you move from concept to commercialization faster while staying compliant. Connect your quality data to your clinical trials to build the "ring fence" of value John Schindler discussed.Feedback Call-to-ActionWe want to hear from you. Did John's take on simplicity change how you view your product roadmap? Do you have a "Founder 101" topic you want us to cover? Send your thoughts, reviews, and suggestions to podcast@greenlight.guru. We read every email and pride ourselves on providing personalized responses to our MedTech community.

In this episode of the Cleft Palate Craniofacial Journal podcast series, Pat Chibbaro, Multimedia Specialist, interviews Stephanie Kraft and Carrie Heike, authors of the CPCJ article entitled, "Ethical Considerations for Clinical Data Sharing in Craniofacial Research: Recommendations From a Multidisciplinary Working Group" (coauthored by Laura Stueckle, Kathleen R. Bogart, Canice Crerand, Kelly N. Evans, Stephanie M. Fullerton, Alexis Johns, Erica Klauber, Sara L. Kinter, Christy M. McKinney, Amy Mendillo, Alexis Prepotente, Amy Schefer, Nicola M. Stock, and Melissa Tumblin)

Dr. Goldhamer introduces water-only fasting, autophagy, visceral fat loss, and detoxification benefits—all grounded in over 50 years of clinical data. #WaterFasting #DetoxScience #Longevity #HealthTalks

Did you know that as MBC patients get treated with multiple lines of ET, the percentage of patients who develop an ESR1 mutation increases? Credit available for this activity expires: 1/26/27 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/current-and-future-oral-serd-strategies-management-er-2026a100022b?ecd=bdc_podcast_libsyn_mscpedu

Following the publication of a peer-reviewed paper in Frontiers in Immunology detailing results from the POLB 001 LPS challenge trial, we catch up with Poolbeg Pharma's CEO Jeremy Skillington and COO Liam Tremble.

“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing them. If your logistics are not better, there is no other differentiator. You need to compete by experience.”When Kostja Paschalidis and his co-founders left their roles developing one of the leading radiopharmaceutical products, they recognised a fundamental shift in pharmaceutical manufacturing. Unlike traditional drugs where marketing drives commercial success, radiopharmaceuticals demand something entirely different: flawless service delivery.As co-founder and head of systems and logistics at Firm, a design consultancy specialising in radiopharmaceutical services, Kostja has identified why operational excellence—not clinical superiority—will determine market winners.In the latest PharmaSource podcast episode, he explains why radiopharmaceutical companies must become service-centric organisations to succeed and how a lack of standardisation and suitable technology creates barriers to scale.

How do you turn messy, unstructured healthcare data into real-time intelligence that actually improves care? In this podcast hosted by Mphasis Vice President of Products Chenny Solaiyappan, Datycs CEO Dr. Srini Rao shares how his career spanning AI at IBM, global telecom infrastructure, and healthcare data engineering led him to tackle one of healthcare's hardest problems: making unstructured clinical data usable at scale. The conversation explores interoperability, NLP versus GenAI in regulated environments, and why real progress in value-based care depends on transforming clinical notes into actionable, standards-based data.

The Lymphoma Hub was pleased to speak to Susan O'Brien, Chao Family Comprehensive Cancer Center, University of California, Irvine, US. We asked, What do the clinical data tell us about fixed-duration ibrutinib + venetoclax for patients with chronic lymphocytic leukemia (CLL)?This educational resource is independently supported by Johnson & Johnson. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource. Hosted on Acast. See acast.com/privacy for more information.

MedBoard   EU Joint clinical assessment procedure -  EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone.   Team-NB proposal for MDR & IVDR - 5 topics on the agenda:  https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR:  SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download   PODCAST Podcast review -  What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh:  https://podcast.easymedicaldevice.com/361-2/

In this in-depth conversation, Dr. Brad Stanfield sits down with Dr Matt Kaeberlein to discuss his journey from a primary care physician in New Zealand to a leading voice in the evidence-based longevity space. We cover the launch and philosophy behind his YouTube channel, the challenges and exciting results of his self-funded rapamycin clinical trial, and his critical perspective on supplements, medical guidelines, and the future of aging research.Dr. Stanfield provides a unique clinician's viewpoint on hot topics like GLP-1 agonists (Ozempic), SGLT2 inhibitors, vitamin D testing, and the pitfalls of biological age clocks. We also dive into a spirited debate on the role of medical societies, the balance between risk and benefit in prescribing medications, and why he believes the field of longevity is still in its early stages of discovery.Key Topics & Timestamps:00:00 - Introduction00:52 - Brad's Background02:47 - Starting the YouTube Channel & Philosophy on Science Communication07:39 - The Rigor of Clinical Data vs. Misinformation10:14 - Admitting Mistakes in Public (Resveratrol, Metformin)14:40 - Funding and Designing the Rapamycin Clinical Trial19:25 - Rapamycin Trial Results Submitted & Plans for a PhD23:28 - Preventative Care: New Zealand vs. US Healthcare Systems27:59 - The Vitamin D Debate: To Test or Not to Test?35:18 - Trust in Medical Guidelines & The Hormone Replacement Therapy Controversy43:42 - The Problem with Biological Age Clocks46:22 - Patient-Centered Care: Inform vs. Decide in Medicine49:49 - How to Judge the Quality of a Clinical Trial (CONSORT)53:44 - Risk vs. Benefit: When Should We Prescribe Preventative Drugs?58:05 - GLP-1 Agonists (Ozempic) and SGLT2 Inhibitors in Practice01:02:00 - Brad's Personal Use of an SGLT2 Inhibitor01:05:38 - The State of Longevity Research: How Much Do We Really Know?01:08:34 - Closing RemarksDISCLAIMER: The information provided on the Optispan podcast is intended solely for general educational purposes and is not meant to be, nor should it be construed as, personalized medical advice. No doctor-patient relationship is established by your use of this channel. The information and materials presented are for informational purposes only and are not a substitute for professional medical advice, diagnosis, or treatment. We strongly advise that you consult with a licensed healthcare professional for all matters concerning your health, especially before undertaking any changes based on content provided by this channel. The hosts and guests on this channel are not liable for any direct, indirect, or other damages or adverse effects that may arise from the application of the information discussed. Medical knowledge is constantly evolving; therefore, the information provided should be verified against current medical standards and practices.Dr. Brad Stanfield's Socials:Website: https://drstanfield.com/YouTube: https://www.youtube.com/@DrBradStanfieldX: https://x.com/BradStanfieldMDMore places to find us:Twitter: https://x.com/Optispan_IncTwitter: https://x.com/mkaeberlein Linkedin: https://www.linkedin.com/company/optispan/Instagram: https://www.instagram.com/optispan_/  TikTok: https://www.tiktok.com/@optispanhttps://www.optispan.life/

Send us a textHealthcare is drowning in messy, inconsistent data, and IMO Health is helping clean it up so organizations can turn information into real clinical insight.In this CareTalk Executive Feature episode, host David E. Williams speaks with John Laursen, Senior Vice President of Commercialization at IMO Health, about how to separate hype from real value in AI healthcare.

What if entrepreneurship could fundamentally change how we experience aging—making it more joyful, independent, and connected? On this special “ICYMI Aging” episode of The Angel Next Door Podcast, host Marcia Dawood brings together highlights from interviews with three pioneering guests who are reinventing what it means to grow older.You'll hear a recap of the insights from Dr. Kerry Burnight, who blends cutting-edge research and family wisdom to prevent elder abuse and loneliness; Hunter Ziesing, who uses tech and AI to personalize healthcare and empower people to own their wellbeing; and Bruce Simpson, an investor building the largest age tech marketplace to help seniors stay independent and financially secure.If you're curious about the future of aging, entrepreneurship, and technology's role in all of it, this episode will give you the highlights. When it comes to aging, having proactive strategies, community, and smart innovations can help us all thrive—at any age. Sign up for Marcia's newsletter to receive tips and the latest on Angel Investing!Website: www.marciadawood.comDo Good While Doing WellLearn more about the documentary Show Her the Money: www.showherthemoneymovie.comAnd don't forget to follow us wherever you are!Apple Podcasts: https://pod.link/1586445642.appleSpotify: https://pod.link/1586445642.spotifyLinkedIn: https://www.linkedin.com/company/angel-next-door-podcast/Instagram: https://www.instagram.com/theangelnextdoorpodcast/Pinterest: https://www.pinterest.com/theangelnextdoorpodcast/TikTok: https://www.tiktok.com/@marciadawood

CME credits: 0.50 Valid until: 11-11-2026 Claim your CME credit at https://reachmd.com/programs/cme/translating-clinical-data-into-multidisciplinary-practice-for-es-sclc/37878/ This online CME program will provide the latest clinical updates on B7-H3–directed antibody-drug conjugates (ADCs) in extensive-stage small cell lung cancer (ES-SCLC). Faculty experts will review the biological rationale for targeting B7-H3 in ES-SCLC and discuss recent clinical evidence on B7-H3 ADCs presented at WCLC and ESMO 2025. Participants will gain practical insights on selecting appropriate patients for B7-H3 ADCs, including efficacy and safety considerations. The program will equip oncology professionals with evidence-based strategies to integrate emerging B7-H3 ADCs into multidisciplinary care for ES-SCLC when they become available.

"But did you bleed him? - Aesculapius says that bleeding is not a cure. It is only a way of proving that you are a physician at the expense of your patient." Finally, we discuss the EPI-321 epigenetic editing phase I/II clinical trial design and its potential for answering key questions necessary for going to phase III and for providing benefit to participants and patients.

Welcome to the Oncology Brothers podcast! In this episode, we kick off a three-part CME series focused on small cell lung cancer (SCLC). Joined by Dr. Hossein Borghaei, Chief of Thoracic Oncology at the Fox Chase Cancer Center. Together they dived into the evolving treatment landscape for SCLC, highlighting recent advancements and data from ASCO 2025. Episode Highlights: •⁠  ⁠Overview of the current standard of care for limited and extensive-stage SCLC. •⁠  ⁠Discussion on the role of concurrent chemoradiation therapy and the new standard of care involving immunotherapy. •⁠  ⁠Insights into the use of lurbinectedin in maintenance therapy and its impact on overall survival. •⁠  ⁠Exploration of the promising results from the DeLLphi study on tarlatamab, a bispecific antibody, and its implications for treatment. •⁠  ⁠The importance of patient selection and managing side effects in treatment decisions. Join us as we navigate the complexities of SCLC treatment and look forward to future advancements that may improve patient outcomes. Accreditation/Credit Designation Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians' Education Resource®, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Acknowledgment of Commercial Support This activity is supported by an educational grant from Jazz Pharmaceuticals, Inc. Link to gain CME credits from this activity: https://www.gotoper.com/courses/breaking-down-the-latest-clinical-data-for-first-line-maintenance-and-rr-sclc  Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ #OncologyBrothers #SmallCellLungCancer #CME #ASCO2025 #LungCancer #Immunotherapy #CancerTreatment

What if you could crack the code to healthcare's most complex data challenges? In this podcast hosted by Chenny Solaiyappan, Virtix Health Vice President of Payer Strategy and Success Tom Shankle will be speaking on clinical data acquisition and healthcare innovation. Tom shares his unique journey from weather forecasting to healthcare leadership, offering insights into how standardized data exchange can revolutionize patient care and healthcare operations.

CME credits: 1.00 Valid until: 31-07-2026 Claim your CME credit at https://reachmd.com/programs/cme/clinical-data-prompting-guideline-updates-for-subcutaneous-icis-in-melanoma/36329/ This online CME activity, presented in collaboration with the National Comprehensive Cancer Network (NCCN®), focuses on translating oncology clinical practice guidelines into practical strategies for treating melanoma. Participants will learn how to integrate clinical trial data into guideline-concordant treatment plans in the neoadjuvant, adjuvant, and metastatic settings. The program highlights the importance of evidence-based approaches and the use of immunotherapy for the treatment of melanoma. Attendees will also explore emerging data that could influence future treatment guidelines, patient case examples, and insights from international faculty to develop region-specific therapeutic tactics aligned with NCCN Guideline® recommendations. *This program was published on July 31st, 2025 and the information therein was up-to-date when created.

CME credits: 1.00 Valid until: 31-07-2026 Claim your CME credit at https://reachmd.com/programs/cme/clinical-data-prompting-guideline-updates-for-subcutaneous-icis-in-melanoma/36329/ This online CME activity, presented in collaboration with the National Comprehensive Cancer Network (NCCN®), focuses on translating oncology clinical practice guidelines into practical strategies for treating melanoma. Participants will learn how to integrate clinical trial data into guideline-concordant treatment plans in the neoadjuvant, adjuvant, and metastatic settings. The program highlights the importance of evidence-based approaches and the use of immunotherapy for the treatment of melanoma. Attendees will also explore emerging data that could influence future treatment guidelines, patient case examples, and insights from international faculty to develop region-specific therapeutic tactics aligned with NCCN Guideline® recommendations. *This program was published on July 31st, 2025 and the information therein was up-to-date when created.

This episode features Ashley Hunsucker and Jan Capps of Connexall as they explore how to transform clinical data into actionable insights. They discuss bridging the gap between technology and bedside care, the power of clinician-IT collaboration, and strategies for continuous improvement in healthcare workflows.This episode is sponsored by Connexall.

At the 2025 Patient Access Collaborative Symposium, Stephanie Schmidt, MS, Senior Director of Ambulatory Operations, and Adam Stone, MS, Director of Clinical Data & Analytics of Oregon Health & Science University led a high-impact workshop on building a culture of data fluency and accountability in access operations. As leaders in both operations and analytics, Stephanie and Adam shared real-world examples of how their teams are aligning key performance indicators (KPIs) with meaningful metrics, using dashboards to bring data to life, and building the infrastructure for consistent governance across departments. Their focus: turning insights into action—and making data not just visible, but transformative.In this episode, they reflect on the collective wisdom shared by access leaders nationwide—from the most common metrics (like fill rate and new patient lag) to the shared barriers (like attribution and cultural resistance). They also unpack the often-overlooked ROI of access initiatives, discuss how to improve organizational fluency, and share their aspirations for the future of access analytics. Whether you're launching a dashboard or leading enterprise-wide transformation, this conversation offers powerful takeaways to guide your next step.

This episode features Ashley Hunsucker and Jan Capps of Connexall as they explore how to transform clinical data into actionable insights. They discuss bridging the gap between technology and bedside care, the power of clinician-IT collaboration, and strategies for continuous improvement in healthcare workflows.This episode is sponsored by Connexall.

In this episode of Data in Biotech, Jesse Paquette, co-founder and Chief Science Officer of Tag.bio, joins Ross Katz to explore how data mesh architecture and FAIR data principles are transforming clinical and research workflows in life sciences. From harmonizing legacy systems to enabling AI-readiness, Jesse shares how Tag.bio empowers domain experts to make data-driven decisions faster and more effectively. ​​What You'll Learn in This Episode: >> How Tag.bio leverages data mesh and FAIR principles to democratize biomedical data access. >> The challenges biotech firms face with legacy infrastructure and clinical trial data. >> The importance of harmonized, version-controlled data products in AI-driven research. >> Why smaller pharma and life sciences firms benefit most from Tag.bio's agile platform. Meet Our Guest Jesse Paquette is the co-founder and Chief Science Officer of Tag.bio, where he leads scientific strategy for AI-powered analytics. With over two decades in life sciences, he specializes in building tools that help researchers interpret complex biomedical data independently. About The Host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyFind out more about Tag.bioConnect with Jesse Parquette on LinkedIn  Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

Please visit answersincme.com/ABT860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in neurology discusses the clinical evidence for novel complement (C5) inhibitors in the treatment of generalized myasthenia gravis (gMG) and personalized multidisciplinary management strategies. Upon completion of this activity, participants should be better able to: Review the rationale for novel C5 inhibitors in the treatment of generalized myasthenia gravis (gMG); Describe the long-term clinical data of C5 inhibitors for the treatment of gMG; and Discuss strategies to personalize multidisciplinary management plans for patients with gMG.

Please visit answersincme.com/ABT860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in neurology discusses the clinical evidence for novel complement (C5) inhibitors in the treatment of generalized myasthenia gravis (gMG) and personalized multidisciplinary management strategies. Upon completion of this activity, participants should be better able to: Review the rationale for novel C5 inhibitors in the treatment of generalized myasthenia gravis (gMG); Describe the long-term clinical data of C5 inhibitors for the treatment of gMG; and Discuss strategies to personalize multidisciplinary management plans for patients with gMG.

Do you know the data well enough to answer patients' questions? Data, workflows, and protocols for successful implementation.  Credit available for this activity expires: 5/27/26 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1002541?ecd=bdc_podcast_libsyn_mscpedu  

Sponsored by: Set For LifeSet For Life Insurance helps doctors safeguard their future with True Own Occupational Disability Insurance. A single injury or illness can change everything, but the best physicians plan ahead. Protect your income and secure your future before life makes the choice for you. Your career deserves protection—act now at https://www.doctorpodcastnetwork.co/setforlife____________In this episode, Dr. Bradley Block interviews Dr. Nini Munoz, who shares strategies to help physicians effectively navigate and combat health misinformation. Known for her platform Nini and the Brain, Dr. Munoz rose to prominence during the COVID-19 pandemic by demystifying complex clinical data. She explains common statistical manipulations, like base rate fallacy and absolute versus relative risk, using examples such as raw milk claims and fluoride debates. Dr. Munoz emphasizes the difference between risk (quantifiable likelihood of harm) and hazard (potential to cause harm), offering strategies to communicate these concepts to patients by aligning with their personal values. From addressing publication bias to advocating humility in science, this episode equips physicians to counter misleading headlines and foster trust with patients.Three Actionable Takeaways:Spot Base Rate Fallacy – Adjust for population size when comparing health outcomes (e.g., pasteurized vs. raw milk hospitalizations) to avoid misleading absolute numbers and reveal true risk.Question Weak Effects – Scrutinize studies with inconsistent or marginal effects, like fluoride research, by checking for confounders, publication bias, or non-replicable results.Tailor Risk Communication – Frame health advice around patients' personal risks (e.g., vaccine benefits for individual healthcare access) to make data relatable and actionable.About the Show:The Physician's Guide to Doctoring 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. Nini Munoz is a PhD-trained electrical engineer and data scientist who gained prominence during the COVID-19 pandemic through her platform Nini and the Brain. Specializing in risk assessment and statistical literacy, she breaks down complex clinical data in English and Spanish, combating misinformation. Dr. Munoz collaborates with virologists, immunologists, and clinicians to make science accessible and advises healthcare organizations like Kaiser Permanente on risk communication strategies.Website: https://www.niniandthebrain.com/Substack: https://substack.com/@techingitapartInstagram: https://www.instagram.com/niniandthebrainThreads: https://www.threads.com/@niniandthebrainAbout 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 The Physician's Guide to Doctoring 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 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.

In this episode, Catherine Fahey, MD, PhD; Alexandra Leary, MD, PhD; Funda Meric-Bernstam, MD; and Zev A. Wainberg, MD, explore the mechanisms of HER2-targeted antibody–drug conjugates (ADCs) and emerging clinical data with these agents across genitourinary, gastrointestinal, and gynecologic cancers.Mechanisms of action of ADCs: how ADCs selectively deliver potent chemotherapy to tumor cellsClinical data across tumor types: highlights from recent trials with trastuzumab deruxtecan and exploration of emerging data on agents such as disitamab vedotinChallenges and future directions:key considerations for combining HER2-targeted ADCs with immunotherapy or chemotherapy, and sequencing ADC therapiesPresenters:Catherine Fahey, MD, PhDAssistant ProfessorDivision of OncologyUniversity of North Carolina at Chapel HillChapel Hill, North CarolinaAlexandra Leary, MD, PhDPresident, GINECO GroupCo-Director, Department of Medical OncologyMedical Oncologist GynecologyTeam Leader, Gynecologic Translational Research Lab, INSERM u981Institut Gustave RoussyVillejuif, FranceFunda Meric-Bernstam, MDChair, Department of Investigational Cancer TherapeuticsMedical Director, Institute for Personalized Cancer TherapyNellie B. Connally Chair in Breast CancerThe University of Texas MD Anderson Cancer CenterHouston, TexasZev A. Wainberg, MDProfessor of Medicine and SurgeryCo-Director of GI OncologyDirector, Early Phase Clinical Research ProgramJonsson Comprehensive Cancer CenterUCLA School of MedicineLos Angeles, CaliforniaLink to full program:https://bit.ly/42iEDjVTo claim credit for listening to this episode, please visit the podcast online at the link above. 

In this information-packed episode of The Red Light Report, Dr. Mike Belkowski is joined by Josh Crawford, Clinical Director of Genoa Integrative Health & Wellness. Josh shares his transformational journey from emergency medicine to building one of the most robust red light therapy clinics in North America. Sparked by the tragic loss of his first wife to Crohn's disease and biologic-related cancer, Josh recounts how that experience ignited his pursuit of root-cause medicine, integrative therapies, and photobiomodulation.   The episode dives deep into the clinical application of red light therapy and methylene blue — especially in combination — as tools for mitochondrial repair, anti-aging, and chronic disease recovery. Josh and Dr. Mike explore the synergistic effects of methylene blue and red light, optimal dosing strategies, and the importance of high-quality supplementation. They also address the challenges of consumer devices, the biohacker movement, and using light and energy to promote cellular regeneration.   Topics include: •  Josh's journey from paramedic to bioenergetic health leader •  Why methylene blue + red light = mitochondrial magic •  Dosing strategies, contraindications, and clinical applications •  How to vet red light therapy devices and avoid snake oil •  Real-world stories of healing from autoimmune, cancer, and neurodegeneration   Whether you're a clinician, wellness entrepreneur, or biohacker, this episode is full of clinical pearls, personal insights, and practical protocols that highlight the future of medicine rooted in energy, light, and mitochondrial health.   Josh Crawford is the Clinical Director of Genoa Integrative Health & Wellness, a leading clinic focused on root-cause healing, mitochondrial repair, and advanced integrative therapies. With a background in emergency medicine and paramedicine, Josh transitioned into the world of holistic health after the tragic loss of his first wife to complications from Crohn's disease and biologic treatment. This personal turning point fueled his mission to challenge conventional sick-care models and pursue modalities that restore cellular health—especially photobiomodulation (red light therapy) and methylene blue. Today, Josh blends clinical insight with cutting-edge technologies to help patients reverse chronic illness, restore vitality, and reclaim their lives. He is widely respected for his hands-on expertise, patient-first philosophy, and ability to bridge traditional medical training with bioenergetic and integrative solutions.   If you found the information in today's episode particularly interesting and/or compelling, please share it with a family member, friend, colleague and/or anyone that you think could benefit and be illuminated by this knowledge. Sharing is caring :) As always, light up your health! - Key points: 00:00 – Introduction 03:18 – Career Shift: From Emergency Medicine to PBM Pioneer 07:05 – Building the Clinic: Canada's Red Light Hub 08:13 – Community Contrast: PBM vs. Conventional Medicine 09:26 – Mitochondria: The Root of Chronic Disease 10:23 – Methylene Blue Basics & Brain Boosting Benefits 11:31 – Red Light + Methylene Blue: Synergistic Power 12:41 – BioLight's Formula: What Makes It Different 13:36 – Why We Don't Say “Cure”: Focus on Balance 15:17 – Methylene Blue in Practice: Cancer & Chronic Cases 17:43 – Prevention > Treatment: The Case for Proactive Healing 20:57 – Synthetic Isn't Evil: Methylene Blue's History 23:25 – Clinical Data: 10,000+ Treatments, 0 Side Effects 25:02 – Empowering Patients: Education Over Blind Trust 26:22 – Curcumin + Methylene Blue: A Healing Combo 27:40 – Chronic Conditions: Extinguish the Fire First 28:08 – The Self-Healing Body: Set the Terrain 30:01 – Zero Harm: What 10,000 Doses Taught Us 31:12 – Inside the Clinic: What Patients Experience 33:27 – Food as Fuel: The Missing Piece in Healing 34:18 – Goldilocks Zone: The Ideal Red Light Dosage 35:19 – Energy & Frequency: Healing at a Cellular Level 37:01 – Frequency Therapy: Rife Tech & Signal Targeting 39:22 – Less is More: Why Overdoing Light Fails 41:28 – Beds Aren't Enough: Deep Healing Requires Precision 42:53 – Mobilizing Stem Cells with Light 44:34 – Brain Work: Lymph Flow & Drainage Support 46:22 – Consumer Devices: Why Most Don't Deliver 49:07 – Tech Specs: Pulsing, Power & What Really Matters 52:41 – The Red Light Market: Navigating Misinformation 55:13 – It's All About Dose: The Turkey Analogy 56:07 – Cooking the Tissue: Why Power Isn't Everything 58:13 – Class IV Lasers: Pain Relief vs. Real Healing 59:28 – Power ≠ Better: The Myth of “More is More” 1:00:08 – Lessons from 80,000+ Treatments 1:01:32 – Wrap-Up: Excitement Around New BioLight Capsules - Watch this episode on YouTube - Upcoming BioLight Events:   Biohacking Conference - May 28 - 30 (Austin, TX)   Returning to Nature (Quantum Health Retreat), June 26 - 27 (Franklin, TN) - Save 25% when you Subscribe & Save to a BioBundle!   For a BioBundle, you choose:1.) Any one BioBlue supplement(BioBlue, BioBlue (SR), BioBlue Leuco, BioBlue Calm, BioBlue Capsules or BioBlue Leuco Capsules)2.) Any one BioC60 supplement(Regular or Concentrated)   The BioBundle automatically saves you 15% on both of the supplements you choose.You save an additional 10% by choosing to Subscribe & Save to that BioBundle.The 25% savings is passed along for every monthly delivery of your BioBundle!No discount code necessary!   Click here to check out The BioBundle - Dr. Mike's #1 recommendations: Water products: Water & Wellness Grounding products: Earthing.com EMF-mitigating products: Somavedic Blue light-blocking glasses: Ra Optics - Stay up-to-date on social media: Dr. Mike Belkowski: Instagram LinkedIn   BioLight: Website Instagram YouTube Facebook

Session 2 ‘Sepsis Epidemiology and Clinical Data' from the 5th World Sepsis Congress. Featuring Mohsen Naghavi, Shevin Jacob, Lisa Mellhammar, Flavia Machado, Lowell Ling, and Eleanor Nwadinobi as your moderator.

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let's clarify all this and give you the right strategies for your Medical Devices. So stay tuned.  Who is Hatem Rabeh?  Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.   With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems.  His expertise covers literature reviews, clinical strategy, and regulatory compliance.   Hatem also shares his knowledge through online training, consulting, and LinkedIn content.  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.  Link Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Given the challenges that our dialysis patients face, how can we as providers stay sharp with the latest access techniques to help ensure the best possible outcomes? Dr. Omar Davis (interventional nephrologist) and Dr. Ari Kramer (general surgeon) join host Dr. Chris Beck to discuss advanced approaches to AV access and share their experiences with the FLEX Vessel Prep device. --- This podcast is supported by: VentureMed FLEX Vessel Prep https://www.venturemedgroup.com/ --- SYNPOSIS The doctors begin by describing how they create dialysis access and what they account for during the procedure. They then focus on the role of the FLEX VP system, its benefits, and how they use it in practice, touching on the latest clinical data. Dr. Kramer and Dr. Davis also stress the importance of mental health in dialysis care and share ways that we can better support our patients through difficult diagnoses and treatments. In fact, one of their patients, Fred Hill, authored the book “Dialysis Is Not Your Life,” which offers a unique perspective for patients feeling overburdened by dialysis, and the healthcare providers who treat them. The episode concludes with case presentations and practical guidance on when to use the FLEX Vessel Prep system. --- TIMESTAMPS 00:00 - Introduction 07:00 - AV Access and Procedures 10:58 - Case Walkthrough 14:19 - Balloon Angioplasty and IVUS 24:43 - Flex VP Device and Vessel Prep 35:03 - Algorithm and Reimbursement Challenges 39:51 - Device Usage and Techniques 46:58 - Clinical Data and Outcomes 01:01:59 - Case Studies --- RESOURCES Fred Hill, “Dialysis Is Not Your Life” Founder and Author: https://www.dialysisisnotyourlife.com/meet-founder.php “Dialysis Is Not Your Life” Book: https://www.amazon.com/DIALYSIS-NOT-YOUR-LIFE-Redefine/dp/B09L4XGGNX Novel Device Prior to Balloon Angioplasty for Dysfunctional Arteriovenous Access: Analysis of a Real-World Registry by Race and Sex Cohorts: https://www.openaccessjournals.com/articles/novel-device-prior-to-balloon-angioplasty-for-dysfunctional-arteriovenousaccess-analysis-of-a-realworld-registry-by-race-and-sex-16852.html FLEX Vessel Prep 12 Month AV Registry Data and 12 Month Belong PAD Data Shows Benefit to Micro-incisions Before Balloon or DCB Treatment: https://www.venturemedgroup.com/wp-content/uploads/2022/12/VEITH-Data-FINAL.pdf Angioplasty with novel, easy-to-use, bladed Flex Vessel Prep system “could replace standard of care”: https://www.youtube.com/watch?v=iRpkrURx1mc Surgical AVF Articles Atlas Condensed - sAVF Overview - Creation Maturation and Difficulties: https://docs.google.com/document/d/1f26FT65s03oZjjeZhBVy8auz0h8PTNvX3CWU5Xi_H5c/edit?usp=share_link Surgical AVF Articles Asif A, Early Arteriovenous fistula failure: https://drive.google.com/file/d/1zZEWgxsdBM4MKCQFjw0U04ra_hB9Ey_N/view?usp=share_link Surgical AVF Articles Asif A - Best Vascular Access in the Elderly - Time for Innovation: https://drive.google.com/file/d/1IpH-KnZyfN5Rqm_kxLnERnEJD6vcjAO8/view?usp=sharing Surgical AVF Articles EV Today - Managing Cephalic Arch Stenosis: https://drive.google.com/file/d/17yVd2M706YCtX-xTK6teesgZqzVIgUoN/view?usp=share_link VentureMed 2024 FLEX Vessel Prep System Reimbursement Guide: https://www.venturemedgroup.com/wp-content/uploads/2024/04/MMA-CTO-15690_FlexVesselPrepSystem-BillingGuide_Lv6-003.pdf BackTable VI Podcast Episode #139 - AV Fistula & Graft Maintenance with Dr. Ari Kramer: https://www.backtable.com/shows/vi/podcasts/139/av-fistula-graft-maintenance BackTable VI Podcast Episode #292 - Dialysis Interventions with Drug-Coated Balloons, Covered Stents and More with Dr. Ari Kramer: https://www.backtable.com/shows/vi/podcasts/292/dialysis-interventions-with-drug-coated-balloons-covered-stents-more

Artificial Intelligence (AI) is revolutionizing healthcare, and oncology is no exception. In this episode of the Exploring AI in Oncology series, Kristin Maloney, MS, BSN, RN, OCN®, a Certified Oncology Nurse and the Clinical Informatics Lead at Mendel AI, speaks with Dr. Waqas Haque on how AI can address some of the biggest challenges in oncology. She shares more about Mendel's innovative platform, which leverages physician-level cognitive capabilities to enhance data process and improve clinical decision making and patient outcomes. Learn more at: https://oncdata.com/mendel-ai-with-kristin-maloney

Did you know androgen deprivation monotherapy is no longer considered standard of care for metastatic hormone-sensitive prostate cancer (mHSPC) by experts? Credit available for this activity expires: 11/25/25 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1001957?ecd=bdc_podcast_libsyn_mscpedu

Host Sandy Vance is behind the mic in this episode with Chris Chang, CEO and Co-Founder at GradientAI. Have any questions for Chris? Reach out via email or check out their website.They explore why GradientAI focuses specifically on the healthcare industry and how its innovative solutions are enhancing patient care and operational efficiency. They also address common concerns surrounding AI adoption and share exciting use cases and future developments. Listen in as Sandy and Chris navigate the intersection of GradientAI and AI in healthcare, revealing the potential to reshape the future of medicine.GradientAI enables enterprises to automate their complex data workflows using its AI-powered data-reasoning platform. They work with many integrated care providers and health tech companies to power processes across the organization, from medical note auditing to the improvement of care to patients, benefit management, claims processing, and data reconciliation. Enterprise AI automation in healthcare, powered by Nightingale - a domain-specific model designed specifically for healthcare.In this episode, they talk about:Why GradientAI Focuses on Healthcare and the Benefits of AI in HealthcareHow GradientAI Helps the Healthcare IndustryPros and Cons of Workflow Tools That Limit Information in HealthcareThe Transformative Technology of AI in the Healthcare IndustryUse Cases, Trials, and Development of AI in HealthcareAddressing Concerns of Those Wary About AI in HealthcareThe Future of GradientAI and AI in HealthcareA Little About Chris:Chris is the Co-Founder and CEO at Gradient, who most recently led Studio AI at Netflix and was an architect of early domain expert LLMs for content production and intelligence. Prior to joining Netflix, Chris held a variety of leadership roles at Pinterest, Opendoor, and Meta. Chris started his career in finance and holds a dual bachelor's degree in computer science and business and a master's degree in computer science from UPenn.

Join us on the Becker's Healthcare Podcast as we speak with Elad Benjamin, Business Leader in Clinical Insights & Integration at Philips, about the critical role of clinical data integration in improving patient outcomes. Learn about the impact of AI, virtual care models, and key strategies for healthcare leaders to support innovation.This episide is sponsored by Philips.

This episode's Community Champion Sponsor is Ossur. To learn more about their ‘Responsible for Tomorrow' Sustainability Campaign, and how you can get involved: CLICK HERE---Episode Overview: How can we harness the power of clinical data to ignite improvement in the healthcare industry? Our next guest, Greg Miller, is on a mission to transform the industry through innovative data solutions at Carta Healthcare. With nearly four decades of experience in healthcare technology, Greg brings a wealth of knowledge in leveraging data to improve outcomes and drive process improvement. While together, Greg shares how he and his team are tackling the challenges of clinical data abstraction, combining artificial intelligence with human expertise to deliver faster, more efficient, and higher quality results. Join us as Greg shares Carta Healthcare's groundbreaking approach to streamlining data collection for clinical registries, reducing costs, empowering healthcare providers with actionable insights and paving the way for a data-driven future in healthcare. Let's go!Episode Highlights:Carta Healthcare's AI-human hybrid approach achieves 85-86% accuracy in automating clinical data abstractionSolution addresses a $10-15 billion industry challenge, reducing costs and improving data qualityGreg discusses healthcare's divided response to AI: fear vs. eager uncertaintyTechnology aims to alleviate workforce shortages by freeing clinicians from data abstraction tasksFuture plans include expanding to more registries and exploring new healthcare applications About our Guest: Greg leads marketing and business development for Carta Healthcare. For almost 40 years, Greg has been driven to transform healthcare, leveraging data to improve outcomes. Miller began his healthcare career within an academic medical center in Boston and for decades he has been leading digital health companies, ranging from startups to Fortune 50 companies, as they apply innovative solutions to drive healthcare process and quality improvement and digital health adoption. Miller's leadership in privately-held, venture-backed companies has resulted in seven acquisitions with meaningful exits and two successful IPO's.Links Supporting This Episode: Carta Healthcare Website: CLICK HEREGreg Miller LinkedIn page: CLICK HERECarta Healthcare LinkedIn page: CLICK HERE Mike Biselli LinkedIn page: CLICK HEREMike Biselli Twitter page: CLICK HEREVisit our website: CLICK HERESubscribe to newsletter: CLICK HEREGuest nomination form: CLICK HERE

In this episode of Cancer Registry World, we are excited to feature two esteemed colleagues from Health Catalyst: Launa Goodman, Clinical Data Program Manager for Oncology, and Allie Coronis, Senior Vice President of Tech-Enabled Managed Services (TEMS). They delve into the crucial role that cancer and other registries play in meeting the global demand for accurate and meaningful data within healthcare enterprises. Enjoy listening and learning!

In this episode, explore the fascinating world of cholesterol dynamics with Dr. Nick Norwitz as he challenges conventional wisdom. Discover the significance of understanding cholesterol risk profiles, particularly in lean mass hyper-responders on a ketogenic diet.   Dive into Dr. Norwitz's bold “Oreo vs. Statin” study, which uncovers surprising insights about cholesterol management. Learn how this experiment highlights the need to reassess traditional approaches to heart health.   Gain valuable knowledge on why LDL cholesterol should not be the sole focus when evaluating cardiovascular risk. Understand the importance of a holistic view that considers individual metabolic health. In This Episode:   00:00 Understanding LDL and Cardiovascular Risk 04:08 Episode Overview: Oreo Cookie Study 07:24 Interview with Dr. Nicholas Norowitz 08:20 The Oreo Cookie Experiment 15:59 Exploring the Lean Mass Hyper Responder Phenomenon 34:43 Understanding VLDL and Triglyceride Metabolism 35:28 The Triad: LDL, HDL, and Triglycerides 36:36 Exploring the Lipid Energy Model 37:30 Insulin's Role in Fat Metabolism 38:22 Clinical Data and Metabolic Profiles 41:20 The Controversy of LDL Particles 46:26 The Lean Mass Hyper Responder Phenotype 52:49 Personal Journey with Ketogenic Diet 58:01 Side Effects of Statin Drugs 01:02:20 Satiety Per Calorie and Marketing Tactics 01:07:47 Conclusion and Final Thoughts   This episode is sponsored by Paleo Valley and their Organic Supergreens powder, a product I love for its high chlorophyll content, which supports blood purification, detoxification, and mitochondrial health. Packed with digestive-supportive superfoods like ginger, lemon, and beet, it's free from cereal grasses, making it gentle on the gut, especially for those with chronic inflammation.   I mix a scoop in water daily, usually after lunch, for an energy boost and mental clarity. You can save 15% on any Paleo Valley product, including their Organic Supergreens, by visiting paleovalley.com/jockers     This podcast is sponsored by ShopC60.com. C60 is a powerful, Nobel Prize-winning antioxidant that helps to optimize mitochondrial function, fights inflammation, and neutralizes toxic free radicals! I'm a big fan of using C60 in conjunction with your keto and intermittent fasting lifestyle to support your immune system, help your body detox, and increase energy and mental clarity. My favorite C60 products for Keto & IF lifestyles include C60 Purple Power in Organic MCT Coconut Oil (you can add this to your coffee) and their delicious Sugar-Free C60 Gummies (made with allulose and monk fruit)! If you are over the age of 40, and you'd like to kick fatigue and brain fog to the curb this year, visit shopc60.com and use the coupon code “JOCKERS” for 15% OFF  and start taking back control over your health today!     “The physiology behind lean mass hyper-responders is an incredible natural experiment, a gift to science.” -Dr. Nick Norwitz   Subscribe to the podcast on: Apple Podcast Stitcher Spotify PodBean  TuneIn Radio     Resources: Visit https://shopc60.com/jockers – Use code “JOCKERS” to get 15% off! Paleovalley's Supergreens - visit paleovalley.com/jockers Oreo Study - https://pubmed.ncbi.nlm.nih.gov/38276308/ Don't be Fooled! A Lesson in Unmasking Pseudoscience - https://www.youtube.com/watch?v=1IWCmFgThQA     Connect with Dr. Nick Norwitz: Twitter: https://x.com/nicknorwitz  Instagram: https://www.instagram.com/nicknorwitz/ YouTube: https://www.youtube.com/channel/UCLTZUJSEulehPtF_ytFiU_A?sub_confirmation=1 Newsletter: https://staycuriousmetabolism.substack.com/   Connect with Dr. Jockers: Instagram – https://www.instagram.com/drjockers/ Facebook – https://www.facebook.com/DrDavidJockers YouTube – https://www.youtube.com/user/djockers Website – https://drjockers.com/   If you are interested in being a guest on the show, we would love to hear from you! Please contact us here! - https://drjockers.com/join-us-dr-jockers-functional-nutrition-podcast/  

Broderick Chavez joins Dave Crosland & Scott McNally to talk all things PED Chapters: 00:00:00 - The Chemical Alteration of Testosterone and its Effects 00:02:35 - An Introduction to Broderick Chavez 00:04:55 - The Beginning of His Fitness Journey 00:07:37 - Developing a Desire for Knowledge 00:10:05 - Training Themes and Cycles 00:12:31 - The History of Steroids and Their Similarities 00:15:12 - The Role of Enzymes in Steroid Metabolism 00:17:49 - The Discovery of Aromatase Enzyme Inhibitors 00:23:04 - A Discussion on Coffee Preferences and Magic Tricks 00:25:37 - Misinterpretation of Research 00:28:10 - Over-relying on Clinical Data 00:30:39 - Open-mindedness and accepting being wrong 00:35:43 - Acid Reflux and Tren Ace 00:38:31 - Training Split for Shift Workers 00:44:03 - The History of Site Injections in Bodybuilding 00:46:26 - Starting a Steroid Cycle 00:49:01 - A Deal with the Devil 00:51:37 - The Risks of Over-taxing Organs in Bodybuilding 00:54:09 - The disconnect in bodybuilding training 00:56:32 - The Importance of Effort and Durability in Training 00:59:04 - Team Evil GSP Branding ✅ Follow Broderick : https://www.instagram.com/teamevilgsp/ ✅ Amino Asylum code THINK for 20% off research chems, peptides, l-carnitine and more https://aminoasylum.shop/ref/122/

In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.

The rise of generative AI has impacted healthcare in many ways – one of which is that it's pushing Big Tech toward becoming not just a relevant, but a central player in the industry. And when we're talking Big Tech, we have to include Google. Google's activity in healthcare has been turbulent since it entered the space nearly two decades ago, but it's impossible to deny the significance of the contributions it's made to the industry. Now with the rapid growth of genAI, Google is refining its healthcare strategy to drive maximum impact in the areas it's best positioned to – places like consumer, therapeutics, diagnostics, and more. At the forefront of this work is Dr. Karen DeSalvo, Google's Chief Health Officer. This week, guest host Eric Larsen, President Emeritus of Advisory Board and President of Towerbrook Advisors sits down with Dr. DeSalvo to unpack the seemingly boundless opportunities of generative AI to evolve healthcare and the unique—and scoped—role Google is playing in helping advance that evolution. Links: Lessons from the C-suite AI in healthcare: Insights from 10 C-suite executives Ep. 197: Lessons from the C-Suite: Demystifying generative AI with Dr. John Halamka, President of Mayo Clinic Platform Ep. 185: AI adoption: why you can't afford to "wait and see" Ep. 180: Tom Lawry on why AI has a PR problem The chronic condition we should be talking about: Challenges and opportunities in migraine care Learn about Advisory Board Fellowship A transcript of this episode as well as more information and resources can be found on radioadvisory.advisory.com.

The Florida Department of Health has Boldly Recommended Against the COVID Booster for People Under 65 years old, Citing the Lack of Clinical Data. Dr. Joseph Ladapo Joins the Program To Discuss Why; The FDA Has Approved the COVD Booster With Virtually No Data. Jefferey Jaxen Breaks Down The Shocking Numbers They DO Have; A New ‘Fruit Film' Lacks appeal; Oncologist, Dr. William Makis, Explores Potential, and Very Possible, Pathways by Which mRNA Vaccines Are Triggering ‘Turbo Cancers.' Guests: Joseph A. Ladapo, M.D., Ph.D., William Makis, M.D.