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
TTKU goes global with Keith Christopher joining from Korea to unpack a busy week of new FDA authorizations, home health innovation, and global regulatory affairs.
Allison and Michael unpack FDA’s generative AI discussion paper, robotic blood draws, medical device reclassifications, exoskeletons, and accessory classifications.
Allison and Michael unpack recent FDA initiatives shaping the future of home healthcare—from AI-powered diagnostics and OTC devices to human factors engineering and reimbursement strategy.
AI-powered diagnostics, ISO 10993 updates, eSTAR 7.0, and the future of biocompatibility. Daysi Diaz-Diestra joins TTKU to unpack another busy week in MedTech.