AI Medical Devices & FDA Pathways: Smart Medicine Podcast with Dr. Yujan Shrestha at Innolitics

Описание: In this episode of the Smart Medicine Podcast, Dr. Ali Fatemi sits down with Dr. Yujan Shrestha, MD, physician—engineer and Partner at Innolitics, to discuss what it truly takes to bring AI medical devices to market.

Dr. Shrestha specializes in AI medical device regulation and clinical validation, guiding software-as-a-medical-device (SaMD) products through FDA pathways including 510(k), De Novo, and Breakthrough programs.

We explore:
• The most common regulatory pitfalls in AI/ML SaMD
• How to choose between 510(k) and De Novo pathways
• What meaningful clinical validation looks like today
• Post-market AI updates and evolving FDA expectations
• Leadership challenges in scaling regulated AI companies
• The future of AI in clinical decision-making

This conversation is essential for medical physicists, radiologists, oncologists, AI founders, and healthcare innovators navigating regulatory strategy and clinical translation.

🎧 Also available on Spotify
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About Smart Medicine Podcast

Smart Medicine explores AI-driven healthcare, medical imaging innovation, radiation oncology, regulatory science, and translational medicine — featuring leaders at the intersection of clinical care, engineering, and entrepreneurship.

Host: Dr. Ali Fatemi
Founder, SpinTecx Consulting
Founder, PrecisionMRI.AI

AI medical device
software as a medical device
SaMD
FDA 510k
FDA De Novo
FDA Breakthrough Device
AI regulation healthcare
medical device validation
clinical validation AI
AI in oncology
AI in radiology
medical physics
healthcare AI startup
regulated AI
Innolitics
Yujan Shrestha
Smart Medicine Podcast
Ali Fatemi