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

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

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 🔔 Subscribe for future episodes on AI, MRI, medical device regulation, and smart healthcare innovation. 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