Trying to Keep Up
with Allison Komiyama & Michael Nilo
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
RAPID pathways, real-time trials, and a major Class I recall—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.