TAP Expansion, RWE Momentum, and FDA Funding Pressures (ft. Kristy Katzenmeyer-Pleuss) – 4/9/26

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TAP Expansion, RWE Momentum, and FDA Funding Pressures (ft. Kristy Katzenmeyer-Pleuss) – 4/9/26

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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Kristy Katzenmeyer-Pleuss for a fast-paced discussion on FDA updates, including Neuropacs De Novo, TAP expansion, real-world evidence adoption, and how funding pressure is reshaping regulatory strategy.

Key Topics Covered:

Neuropacs De Novo: AI-driven Parkinsonian diagnostic and its clinical implications
NEXUS Aortic Arch Stent Graft PMA: key features and use cases
FDA READI Home Innovation Challenge: advancing home-based care technologies
Real-World Evidence (RWE): FDA’s 73 published examples and what they signal
TAP Program Expansion: new offices, broader access, and practical impact
Breakthrough + TAP dynamics: where programs help and where gaps remain
Funding pressure in MedTech: how investor milestones drive premature FDA interactions
White Oak 66 venture launch: former FDA leaders shaping early-stage investment strategy
EU MDR vs U.S. expectations: leveraging existing clinical data across regions
Post-market vs pre-market shift: industry push toward risk-based regulatory strategies
FDA staffing changes: hiring, attrition, and impact on review timelines
Operational frustrations: delayed summaries, outdated org charts, and transparency gaps

Links:

Neuropacs
Neuropacs De Novo decision summary
NEXUS Aortic Arch Stent Graft System
FDA READI Home Innovation Challenge
FDA Real-World Evidence Examples (73 cases)