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.
Chapters
02:26 Introduction to BioTalk Unzipped
03:40 Charity Spotlight: Americares
05:01 Dr. Alex Friedman's Career Journey
11:52 The Regulatory Landscape of Medical Device Classifications
18:52 Regulatory Gameshow!: Classifying Medical Devices
22:28 AI Enabled Software as a Medical Device: An Overview
25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike
30:31 The Evolution of Wearable Health Technology
41:17 Liability and Risk in Medical Device Development
43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare
47:13 Self Updating AI Doctors?? - The Future of AI in Public Health
49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box
56:27 New News!! - The Intersection of AI, Regulation, and Innovation
01:07:28 Measuring Success in Life and Work
HOW TO REACH US:
Alex Friedman
https://www.linkedin.com/in/alexfriedman/
Alex’s Charity: Americares
Dr. Chad Briscoe
https://www.linkedin.com/in/chadbriscoe/
Celerion - https://www.celerion.com/
Gregory Austin
https://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 data
New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech
Mentioned in the podcast:
Concussion Mouthguard Sensors:
SISU Sense - https://www.sisuguard.com/sisusense/
HIT-IQ - https://www.hitiq.com/smart-mouthguard
Prevent Biometrics - https://preventbiometrics.com/
IDX-DR - Diagnosing Software
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