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Are AI Doctors coming soon? A Discussion about AI in Medical Devices. - with Dr. Alex Friedman
Episode 303rd February 2025 • BioTalk Unzipped • BioTalk Unzipped
00:00:00 01:10:28

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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


https://www.americares.org/ 


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


https://www.healthvisors.com/en/idx-dr/ 




Sound Bites


"The common thread is the science."


"Regulatory has to catch up."


"You can't sell snake oil."


"It's a multidisciplinary effort."


"Software as a medical device is a hot thing."


Image Credits:


Aliens - 


https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/


https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/


keywords


medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs

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