{"podcast":{"title":"BioTalk Unzipped","slug":"biotalk-unzipped-6702602","podcast_index_feed_id":6702602,"rss_url":"https://feeds.captivate.fm/biotalk-unzipped/","website_url":"https://www.biotalkunzipped.com","image_url":"https://artwork.captivate.fm/bc8c17ac-b08b-4ac4-b89d-c3f29318523c/updated-BioTalk-Logo.png","author":"Gregory Austin","episode_count":46,"summary":"BioTalk Unzipped, hosted by Gregory Austin and Dr. Chad Briscoe, unzips the stories behind medical progress through candid, intelligent, and often entertaining conversations with leaders across biotechnology, pharmaceuticals, medical technology, clinical research, bioanalysis, and drug development. Each episode explores the science, strategy, setbacks, breakthroughs, and human stories shaping the future of medicine. From first-in-human trials and biomarkers to oncology, rare disease, AI, regulatory strategy, and emerging therapeutic technologies, BioTalk Unzipped makes complex life science topics engaging, accessible, and relevant. The show feels like the conversation you would want to overhear after a great scientific conference: thoughtful, unscripted, curious, and grounded in real-world experience. We bring listeners inside the decisions, discoveries, and personal journeys behind the therapies and technologies that may one day reduce suffering and improve lives.","last_synced_at":"2026-09-11T10:23:01.173868+00:00","page_url":"https://stenobird.com/podcast/biotalk-unzipped-6702602"},"episode":{"title":"Can AI Become Your Doctor? FDA Regulation, Medical Devices & the Future of Healthcare","slug":"are-ai-doctors-coming-soon-a-discussion-about-ai-in-medical-devices-with-dr-alex-friedman","published_at":"2025-02-03T07:39:00+00:00","page_url":"https://stenobird.com/podcast/biotalk-unzipped-6702602/are-ai-doctors-coming-soon-a-discussion-about-ai-in-medical-devices-with-dr-alex-friedman","show_page_url":"https://stenobird.com/podcast/biotalk-unzipped-6702602","url":"https://biotalk-unzipped.captivate.fm/episode/are-ai-doctors-coming-soon-a-discussion-about-ai-in-medical-devices-with-dr-alex-friedman","audio_url":"https://episodes.captivate.fm/episode/69c8f32c-49f5-459c-8a0f-12b066daacbb.mp3","summary":"Could artificial intelligence become your doctor someday? In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alex Friedman, a regulatory affairs expert with deep experience in medical devices, FDA submissions, quality systems, and AI-enabled Software as a Medical Device. Alex helps unpack one of the most important questions in healthcare innovation: when does software become a regulated medical device, and what happens when AI begins influencing clinical decisions? The conversation moves from classic medical device classifications to 510(k) submissions, De Novo pathways, wearable health technology, clinical decision support software, adaptive AI, liability risk, and the future of “doctor-in-a-box” tools for underserved communities. This episode is especially relevant for medical device developers, digital health founders, regulatory affairs professionals, biotech leaders, clinicians, investors, and anyone trying to understand how AI will be safely integrated into healthcare. Alex explains why regulatory strategy is not just bureaucracy. It is a public health safeguard designed to protect patients, validate claims, and prevent companies from selling unproven technology into high-stakes clinical environments. As he puts it in the episode, “You can’t sell snake oil.” In this episode How FDA classifies medical devices by risk Why many Class II devices follow the 510(k) pathway What “substantial equivalence” means When software becomes a medical device Why AI-enabled software raises new regulatory questions How wearable technology may change cardiovascular monitoring Why medical claims create liability risk What makes adaptive AI especially difficult to regulate How FDA may approach predetermined change control plans Why inclusive tra…","meta_description":"Could artificial intelligence become your doctor someday? In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alex…","key_points":[],"chapters":[],"topics":[],"duration_seconds":4140,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/biotalk-unzipped-6702602/episodes/are-ai-doctors-coming-soon-a-discussion-about-ai-in-medical-devices-with-dr-alex-friedman/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/biotalk-unzipped-6702602/are-ai-doctors-coming-soon-a-discussion-about-ai-in-medical-devices-with-dr-alex-friedman.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}