A weekly podcast where regulatory nerds talk about what's actually happening at the FDA's CDRH and how it's affecting real teams, real timelines, and real decisions
Jay Vaishnav joins to discuss AI diagnostics, PCCPs, FDA review trends, human factors guidance, and the future of medtech regulation.
Former FDA leader Vivek Pinto joins to discuss RAPID, real-world evidence, patient-focused development, PMAs, and the future of device review.
Dave McGurl joins to talk FDA leadership drama, AI therapy bots, PTSD neurotech, surprise inspections, and neurosurgical patties.
Josh Levin joins to talk FDA AI warning letters, cybersecurity concerns, real-world evidence, ELSA 4.0, and the future of precision medicine.
