In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device. Chapters02:26 Introduction to BioTalk Unzipped03:40 Charity Spotlight: Americares05:01 Dr. Alex Friedman's Career Journey11:52 The Regulatory Landscape of Medical Device Classifications18:52 Regulatory Gameshow!: Classifying Medical Devices22:28 AI Enabled Software as a Medical Device: An Overview 25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike30:31 The Evolution of Wearable Health Technology41:17 Liability and Risk in Medical Device Development43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare47:13 Self Updating AI Doctors?? - The Future of AI in Public Health49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box56:27 New News!! - The Intersection of AI, Regulation, and Innovation01:07:28 Measuring Success in Life and WorkHOW TO REACH US:Alex Friedmanhttps://www.linkedin.com/in/alexfriedman/ Alex’s Charity: Americareshttps://www.americares.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device datahttps://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTechhttps://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersectMentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/  HIT-IQ -

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