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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  • De Novos, Drama & a Very Cool Heart Valve
    3/26/26

    De Novos, Drama & a Very Cool Heart Valve

    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.

  • GenAI, TEMPO & Digital Health Reality
    3/19/26

    GenAI, TEMPO & Digital Health Reality

    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 & Ortho Innovation
    3/12/26

    FDA Hiring, AI Imaging & Ortho Innovation

    FDA hiring, AI imaging surprises, and real-world orthopedic innovation—plus insights from former FDA leader Melissa Hall on navigating today’s regulatory landscape.

  • FDA's “Valentine’s Day Massacre”
    3/5/26

    FDA's “Valentine’s Day Massacre”

    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.