Trying to Keep Up

with Michael Nilo & Allison Komiyama

A man and a woman smiling, sitting close together, with a blue and yellow logo labeled "TTKU" in between them, against a black background.

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

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  • Can FDA Keep Up with Generative AI?
    6/25/26

    Can FDA Keep Up with Generative AI?

    AI is changing medtech faster than ever. Alex Cadotte joins Allison and Michael to discuss generative AI, PCCPs, cybersecurity, human factors, and what companies should expect from FDA.

  • Sibling Takeover: AI Devices, SNOO & CGMs
    6/18/26

    Sibling Takeover: AI Devices, SNOO & CGMs

    Erin Gontang and Nick Nilo join TTKU for a family edition covering AI devices, PMAs, sensor-based technologies, SNOO, CGMs, and FDA updates.

  • The State of Clinical Research
    6/11/26

    The State of Clinical Research

    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.

  • The Future of Brain Stimulation
    6/4/26

    The Future of Brain Stimulation

    Former FDA neuroscientist Laura Rice joins TTKU to discuss PTSD neurotech, brain stimulation, AI diagnostics, and the future of neuroscience innovation.