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
The team breaks down FDA guidance shakeups, SaMD confusion, reviewer pressures, and the medtech chaos kicking off 2026.
The team unpacks the medtech industry’s growing obsession with Breakthrough, STeP, and TAP—and what it says about FDA strategy in 2026.
The team unpacks FDA wellness policy updates, startup funding pressure, AI-generated submissions, JPM insights, and digital health uncertainty.