Podcasts
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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
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Diagnostics
RSIP Vision’s Diagnostic Imaging Advancements
MPO's Sean Fenske speaks with Moshe Safran of RSIP Vision about the emerging tools that are moving imaging forward.Sean Fenske, Editor-in-Chief 01.25.22
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FDA’s Cybersecurity Playbook—Mike on Medtech
Mike Drues and Sean Fenske discuss why cybersecurity is important to the Agency and how to address challenges involved with it.Sean Fenske, Editor-in-Chief 01.20.22
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Surgical
Video Capture of Surgery with Theator
MPO's Sean Fenske speaks with Dr. Tamir Wolf of Theator about the benefits of capturing surgical procedures on video.Sean Fenske, Editor-in-Chief 01.18.22
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Digital Health
GE Healthcare’s Chief Digital Officer’s 2022 Predictions
MPO's Sean Fenske speaks with Amit Phadnis of GE Healthcare shares his predictions on healthcare technology and the changes it will cause.Sean Fenske, Editor-in-Chief 01.13.22
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Surgical
DePuy Synthes Strives for Knee Restoration
MPO's Sean Fenske speaks with Andrew Ekdahl of DePuy Synthes about the company’s quest to achieve knee restoration rather than replacement.Sean Fenske, Editor-in-Chief 01.11.22
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Femasys Targets Fertility and Women’s Health
MPO's Sean Fenske speaks with Kathy Lee-Sepsick of Femasys about how the company is addressing infertility as well as preventing pregnancy.Sean Fenske, Editor-in-Chief 01.06.22
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Cardiovascular
Front Line’s COBRA-OS Helps Prevent Bleed Out
MPO's Sean Fenske speaks with Dr. Asha Parekh of Front Line Medical on the functionality of the company’s device and how it can help save lives.Sean Fenske, Editor-in-Chief 01.04.22
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Surgical
Pristine Surgical’s Single-Use Endoscopes
MPO's Sean Fenske speaks with Bryan Lord of Pristine Surgical about the advantages of single-use endoscopes and why they are necessary.Sean Fenske, Editor-in-Chief 12.14.21
