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
Erin Gontang and Nick Nilo join TTKU for a family edition covering AI devices, PMAs, sensor-based technologies, SNOO, CGMs, and FDA updates.
With Allison away this week, Michael Nilo and Caroline Rhim discuss clinical trial challenges, myopia innovation, reimbursement strategy, and the latest FDA developments shaping MedTech.
Former FDA neuroscientist Laura Rice joins TTKU to discuss PTSD neurotech, brain stimulation, AI diagnostics, and the future of neuroscience innovation.
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.
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.
The team breaks down major FDA De Novos, PMAs, breakthrough devices, and melanoma reclassification updates—including sleep apnea tech, heart valves, home diagnostics, and the future of medtech innovation.
Aubrey Shick joins to break down how the FDA is approaching generative AI, what TEMPO submissions reveal about evolving policy, and why digital health still lives in regulatory gray zones.
FDA hiring, AI imaging surprises, and real-world orthopedic innovation—plus insights from former FDA leader Melissa Hall on navigating today’s regulatory landscape.
A former FDA reviewer shares what really happened during mass layoffs—plus De Novo updates, a new PMA approval, and what AI changes could mean for MedTech.
The team unpacks reclassifications, AI pregnancy tech, weight loss balloons, and FDA’s latest moves in digital health, orthopedics, and rare disease policy.
The team unpacks reclassifications, AI pregnancy tech, weight loss balloons, and FDA’s latest moves in digital health, orthopedics, and rare disease policy.
The team unpacks the truth behind breakthrough designation, FDA review realities, new cancer technologies, and the return of CDRH News.
QMSR officially launches, FDA rolls out Tempo, and Allison Kumar joins TTKU to unpack PMAs, guidance updates, hiring, and real-world evidence.
The team unpacks FDA wellness policy updates, startup funding pressure, AI-generated submissions, JPM insights, and digital health uncertainty.
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 breaks down FDA guidance shakeups, SaMD confusion, reviewer pressures, and the medtech chaos kicking off 2026.