AI Medical Devices & FDA Pathways: 510(k), De Novo & SaMD Strategy | Smart Medicine Podcast with Dr. Yujan Shrestha at Innolitics

In this episode of the Smart Medicine Podcast, Dr. Ali Fatemi speaks with Dr. Yujan Shrestha, MD, physician–engineer and Partner at Innolitics, about AI medical device regulation and clinical validation.We discuss FDA pathways, including 510(k), De Novo, and Breakthrough programs, common regulatory pitfalls in AI/ML software as a medical device (SaMD), post-market model updates, and how AI will reshape clinical decision-making in oncology and beyond.Smart Medicine explores the intersection of AI, medical imaging, regulation, and healthcare innovation.AI in healthcareregulated AImedical device innovationclinical AI validationFDA medical devicesAI in oncologydigital health regulation