This week on Trying to Keep Up, Allison and Michael unpack a major De Novo clearance, debate the real value of Breakthrough and STeP designations, and highlight what’s changing across the regulatory landscape.

They cover the Bridge to Life perfusion device milestone, Sana Health’s emerging technology, and the newly released Total Product Lifecycle Advisory Program (TAP) pilot assessment report. The conversation also dives into the growing pressure for companies to pursue Breakthrough status—and whether the regulatory and reimbursement benefits actually deliver.

Plus: conference chatter (LSI, JPM, CES), FDA updates, and a shoutout to new RAC certificants.

If you’re navigating device strategy in 2026, this episode helps you separate signal from noise.

Key Topics Covered

• De Novo clearance for Bridge to Life’s perfusion device
• Sana Health and emerging light-based therapeutics
• Breakthrough vs. STeP vs. TAP: expectations vs. reality
• TAP Pilot Assessment Report and program implications
• FDA resource constraints and impact on program timelines
• Reimbursement challenges post-clearance
• Conference insights: LSI, JPM, CES
• RAC certification announcements and industry milestones
• FDA’s 125th anniversary and agency updates

Links

• TAP Pilot Assessment Report
• TEMPO Federal Register Notice

Stay Connected

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group

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