Trying to Keep Up
with Michael Nilo & Allison Komiyama
A weekly live call where two 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
A weekly live call where two 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
Véronique Li joins to unpack RAPID pathways, real-time trials, a major Class I recall, and what it all means for MedTech right now.
A candid breakdown of the latest De Novo device, FDA Town Hall insights, and what’s really happening behind the scenes with hiring, transparency, and regulatory expectations.
A “quiet” FDA week reveals more than expected—HDE insights, AI compliance risks, and growing trust concerns.
A packed FDA week: neuropacs™ De Novo, TAP expansion, real-world evidence momentum, and how funding pressure is reshaping regulatory strategy.
Allison and Michael break down FDA updates, including real-world evidence, hiring trends, and TAP program expansion—plus a look at global medtech impact.