This week on Trying to Keep Up, Allison Komiyama and Michael Nilo unpack the latest FDA digital health developments, startup funding realities, and the growing uncertainty around general wellness policy.

The conversation dives into FDA’s upcoming General Wellness Town Hall, newly released draft guidance on cuffless blood pressure devices, and the ripple effects of recent software guidance changes. Allison and Michael also discuss how medtech startups are navigating tighter budgets, where companies are making risky cost-cutting decisions, and why quality systems still matter even when funding gets thin.

They also recap what they’re hearing from JPMorgan Healthcare Week, reflect on the passing of legendary medtech innovator Thomas Fogarty, and debate whether AI-generated 510(k)s are helping—or creating bigger regulatory problems.

Plus: pirate eye patches, ophthalmology jokes, and FDA social media commentary.

Key Topics Covered

• FDA General Wellness Policy Town Hall

• FDA Draft Guidance: Cuffless Blood Pressure Devices

• Digital health and Software as a Medical Device (SaMD) changes

• Medtech fundraising and JPMorgan Healthcare Conference trends

• Startup quality system risks and regulatory shortcuts

• AI-generated regulatory submissions

• Fraudulent test lab concerns

• Remembering Thomas Fogarty and the Stanford Biodesign legacy

• FDA LinkedIn and Instagram strategy