Are AI Doctors coming soon? A Discussion about AI in Medical Devices. - with Dr. Alex Friedman

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

• https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424
• 
  
• 
  

New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech

• https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect
• 
  
• 
  

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