Medical Device
46 videos · last 6 months shuffled daily, then older videos newest first
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56:55 FDA LDT Rule Vacated: What IVD Developers Need to Know
Jesse Young of TriCore Reference Laboratories and Dan Simpson of DCN Dx explain what the 2025 court decision vacating FDA's laboratory-developed test rule did and did not settle for IVD developers and clinical labs, on DCN Dx's Expert Insights.
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1:46:58 From Wellness App to Digital Health Application: Building a Digital Therapeutic in Europe - E5
GCP-Mindset's Beyond Outcomes talks to Vitadio co-founder Lenka Šomvárska about generating clinical evidence, CE marking and the MDR transition for a type 2 diabetes digital therapeutic.
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4:17 Wearable Monitor for Postpartum Bleeding in Global Study
InvestigateTV reports that Woman's Hospital is testing Baymatob's Oli wearable monitor, designed to detect warning signs of postpartum hemorrhage, as one of the first US hospitals in a global study of the device.
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3:59 Envoy Medical Announces Key Progress in Pivotal Acclaim® Cochlear Implant Study
Envoy Medical CEO Brent Lucas on the pivotal trial of the fully implanted Acclaim cochlear implant: first-stage enrolment and activation complete, and a first data release.
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1:22:40 Beyond Outcomes Podcast E1: How One Founder Turned a Personal Disease Into a Medical Device Company
Jan Elsner, founder of Skinuvita, on building a device that brings medically supervised phototherapy into patients' homes, and how his own psoriasis shaped it.
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1:25:17 Beyond Snapshot Diagnostics: The Future of Continuous Health Monitoring - Beyond Outcomes Podcast E2
Dr. Andreas Beust speaks with Dr. Agnes Musiol, founder of pheal, about moving from clinical research into medical device work, and about monitoring the body continuously rather than in single snapshots.
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14:34 ARIES HM3: Avoiding Aspirin With LVADs
Dr. Mandeep Mehra and Dr. C. Michael Gibson discuss the primary results of ARIES HM3, an international, double-blind, placebo-controlled trial of avoiding aspirin in advanced heart failure patients with left ventricular assist devices, for Snackable Health.
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45:05 Evolving Landscape of Temporary Wound Coverage: Clinical Evidence and Experience with PermeaDerm®
Surgeons present results from the PermeaDerm-I randomized controlled trial of a biosynthetic wound matrix as an alternative to cadaveric allograft, including clinical and economic outcomes.
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5:43 ASPIRED: Ambulatory ECG Monitoring in Unexplained Syncope
Matthew Reed, MD, and C. Michael Gibson, MD, discuss ASPIRED, a multi-centre open-label randomised trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in patients with acute unexplained syncope.
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5:11 Neuralink Clinical Trials for Brain Computer Interface and the Dura
Neuralink on inserting its implant's electrode threads through the intact dura into the cortex for the first time in its clinical trials, at Toronto Western Hospital.
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39:24 Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
Greenlight Guru talks to Ali Samiian of Popular Access Advisors about MedTech reimbursement, the FDA's TAP program and the CMS RAPID program.
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8:59:50 FDA Advisory Panel on GRAIL's Galleri Cancer Test
The FDA's Molecular and Clinical Genetics Panel meets to discuss and vote on GRAIL's premarket approval application for the Galleri multi-cancer early detection blood test.
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21:08 UK CCTS - CRSO: Devices & Clinical Research: A Refresher on Billing & Regulatory Requirements
Sara Kuhl, Kate Applegate and Renee Hensley on the FDA and CMS rules governing devices in clinical research, and how billing works under them.
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2:19:14 GCP-Mindset on Evidence Standards in European Medical Device Regulation
Andreas Beust talks to Prof. Tom Melvin about whether European medical device regulation gives innovators enough clarity, covering early regulatory advice, randomized trials, registries, real-world evidence, orphan and paediatric devices, and what Europe might take from the US, Japan and the UK.
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17:18 High-Risk AI Requirements for AI-Based Medical Devices: What the EU AI Act Adds to MDR Compliance
GCP-Mindset on Germany's new roadmap for AI-enabled medical devices and how EU AI Act requirements fit with existing MDR obligations.
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54:51 Deborah Morley, RQM+, on Cardiovascular Device Development
Deborah Morley, Director, Cardiovascular Strategy and Delivery at RQM+, draws on her work with Class III implantable cardiovascular devices such as LVADs to discuss device development, regulatory approval and clinical adoption, for bioaccess.
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1:00:03 Nanochon CEO on a 3D-Printed Cartilage Implant
Ben Holmes, PhD, CEO and Co-Founder of Nanochon, discusses Chondrograft, a 3D-printed synthetic implant designed to repair damaged knee cartilage, and the company's path toward its first-in-human clinical trial, for bioaccess.
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2:21 OSPREY Study: Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
Atul Malhotra, MD, University of California San Diego, San Diego, CA, provides an overview of the OSPREY study (NCT04950894) evaluating proximal hypoglossal nerve stimulation for obstructive sleep apnea.
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2:06 Defining Clinical Endpoints for Neurointervention Trials
Alexandra J. Lansky summarises a PCR-EAPCI Textbook chapter on consensus definitions and assessment of neurological endpoints for clinical trials in neurointervention, for PCR.
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31:39 Heart Failure Shunt Trial: Alt Flow
The University of Kansas Health System's All Things Heart discusses a clinical trial testing whether shunts placed inside the heart can help blood flow properly and reduce pressure in heart failure.
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2:08 What Is an Adaptive Clinical Trial Design for Medical Devices?
NAMSA's Tyson Rogers on what makes a clinical study design adaptive, and how it differs from other designs.
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1:46 Clinical Trials of Sensor at Walter Reed
A flexible wearable electronic device sensor is in clinical trials at Walter Reed Medical Center.
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21:42 Device Regulatory Submissions and Trials, Part 1
Former FDA lead reviewer Ryan Randall and Amie Smirthwaite, RQM+ Senior VP of Scientific Affairs, discuss how reviewers assess clinical data, benefit-risk, failed primary endpoints and protocol adherence in US and EU device submissions.
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1:40 The Sound and the Fury: Clinical Trial Uses Sound Waves to Treat Liver Tumors
A clinical trial for liver tumors using non-invasive technology is described in this video from a local Florida news station.