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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  • AI, 513(g)s & FDA Reorganization
    7/30/26

    AI, 513(g)s & FDA Reorganization

    Matt Trachtenberg joins TTKU to discuss AI in regulatory affairs, FDA reorganization, RAPID, robotic surgery, companion diagnostics, and why 513(g) requests remain controversial.

  • MDUFA VI, TEMPO & FDA's Next Moves
    7/23/26

    MDUFA VI, TEMPO & FDA's Next Moves

    Former FDA leader Mike Ryan joins TTKU to discuss MDUFA VI, TEMPO, Breakthrough Devices, AI-enabled technologies, and what FDA's latest initiatives mean for MedTech.

  • FDA’s AI, AR & Third-Party Review Debate
    7/16/26

    FDA’s AI, AR & Third-Party Review Debate

    Dulciana Chan joins TTKU to discuss augmented reality surgery, AI breakthroughs, FDA third-party reviews, HDE challenges, and the latest MedTech updates.

  • Pre-Sub Fees, MDUFA VI & TEMPO Updates
    7/9/26

    Pre-Sub Fees, MDUFA VI & TEMPO Updates

    Allison and Michael discuss the Claria System, FDA's proposed Pre-Sub fees, TEMPO updates, women's health research, and MDUFA VI.

  • Gene Therapy, TAP Growth & Lung Preservation
    7/2/26

    Gene Therapy, TAP Growth & Lung Preservation

    Holiday week didn't slow the FDA down. Allison and Michael discuss new PMAs, pediatric gene therapy expansion, TAP enrollment growth, organ preservation technologies, and software guidance updates.