Podcasts
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AI Predetermined Change Control Plan—Mike on Medtech
Mike Drues and Sean Fenske discuss an FDA guidance that would outline how AI or ML technologies could be allowed to evolve without new submissions.Sean Fenske, Editor-in-Chief 09.19.23
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Can You Use a Recalled Device as a Predicate?—Mike on Medtech
Mike Drues and Sean Fenske discuss why and how a medical device manufacturer might use a device that went through a recall as a predicate for a new product.Sean Fenske, Editor-in-Chief 06.20.23
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Leading Issues from FDA Inspections (or History Repeating Itself)—Mike on Medtech
Mike Drues and Sean Fenske discuss why medical device manufacturers continue to rack up the same types of 483s from FDA inspections.Sean Fenske, Editor-in-Chief 04.04.23
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Diagnostics
To Regulate or Not to Regulate…LDTs, Part 2—Mike on Medtech
Mike Drues and Sean Fenske continue the discussion on the controversy involving LDTs and whether the FDA should regulate them.Sean Fenske, Editor-in-Chief 02.07.23
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Diagnostics
To Regulate or Not to Regulate…Lab Developed Tests, Part 1—Mike on Medtech
Mike Drues and Sean Fenske review the controversy surrounding lab developed tests and discuss whether or not it makes sense for FDA to regulate them.Sean Fenske, Editor-in-Chief 01.31.23
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What Happens When the EUA Period Ends?—Mike on Medtech
Mike Drues and Sean Fenske discuss what happens when the emergency use authorization period ends and what device makers need to do then.Sean Fenske, Editor-in-Chief 12.13.22
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What Does 510k Exempt Actually Mean?—Mike on Medtech
Mike Drues and Sean Fenske review the term and discuss what types of devices are exempt, as well as the meaning of the term itself.Sean Fenske, Editor-in-Chief 11.29.22
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How Can Off-Label Use Be Promoted?—Mike on Medtech
Mike Drues and Sean Fenske look at the promotion of off-label use for a medical device and the ways in which it can be done successfully.Sean Fenske, Editor-in-Chief 11.15.22
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FDA's Intended Use Rule’s Relation to Labeling—Mike on Medtech
Mike Drues and Sean Fenske review the agency’s Intended Use rule that was made final last year and discuss its impact on labeling.Sean Fenske, Editor-in-Chief 11.01.22
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Gaining an Advantage Through Class II Special Controls—Mike on Medtech
Mike Drues and Sean Fenske look at the FDA’s Special Controls that are tied to Class II medical devices and how they can be leveraged by a company.Sean Fenske, Editor-in-Chief 10.25.22
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FDA’s Refusal to Accept Policy for 510(k)s—Mike on Medtech
Mike Drues and Sean Fenske review the latest guidance on Refuse to Accept and why the occurrence happens much too often.Sean Fenske, Editor-in-Chief 10.18.22
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Initiating a Voluntary Medical Device Recall—Mike on Medtech
Mike Drues and Sean Fenske discuss recalls with a specific focus on voluntary recalls, why they occur, and how to be ready for one.Sean Fenske, Editor-in-Chief 10.11.22
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A Letter to File Deep Dive—Mike on Medtech
Mike Drues and Sean Fenske discuss how a letter to file is to be used, when to use it, and how to avoid problems with FDA.Sean Fenske, Editor-in-Chief 10.04.22
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Humacyte’s Bioengineered Tissue Platform Technology
MPO's Sean Fenske speaks with Dr. Juliana Blum of Humacyte about the company’s regenerative medicine product.Sean Fenske, Editor-in-Chief 03.08.22
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Chronic Disease
Koya Medical Restores Mobility for Compression Therapy Patients
MPO's Sean Fenske speaks with Andy Doraiswamy of Koya Medical about providing compression therapy on-the-go.Sean Fenske, Editor-in-Chief 03.01.22
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Neurological
NeuroPace’s Aid in Tracking and Treating Epilepsy
MPO's Sean Fenske speaks with Mike Favet of NeuroPace about a strategic partnership and what it means for those suffering from epilepsy.Sean Fenske, Editor-in-Chief 02.22.22
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Diagnostics
Aidoc Is Improving Patient Outcomes Through AI
MPO's Sean Fenske speaks with Elad Walach of Aidoc about the incorporation of AI in radiology.Sean Fenske, Editor-in-Chief 02.15.22
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Performing a Gap Analysis on FDA's Regulatory Protocols—Mike on Medtech
Mike Drues and Sean Fenske discuss what may be missing from the FDA’s regulatory oversight and opportunities they could offer.Sean Fenske, Editor-in-Chief 02.08.22
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Surgical
Stereotaxis’ Robotic Surgery System for Interventional Procedures
MPO's Sean Fenske speaks with David Fischel of Stereotaxis about his company’s unique robotic surgical system.Sean Fenske, Editor-in-Chief 02.01.22
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Chronic Disease
Fighting Tumors with Varian’s FLASH Technology
MPO's Sean Fenske speaks with Dr. Deepak Khuntia of Varian about the firm’s one-second radiation system for tumors.Sean Fenske, Editor-in-Chief 01.27.22
