Michael Nilo is out this week, but the show must go on. Allison Komiyama welcomes longtime FDA colleague and regulatory strategist Caroline Rhim for a fast-moving conversation on breakthrough devices, FDA review realities, new cancer technologies, and the return of CDRH News.

They unpack two newly authorized devices making headlines: the Amferia Wound Dressing De Novo and the Optune Pax PMA for pancreatic cancer treatment. Caroline explains how tumor treating fields work, why the technology is so compelling, and what these approvals could signal for the future of medical devices.

The conversation then shifts to one of the biggest topics in medtech right now: FDA Breakthrough Device Designation and TAP. Allison and Caroline discuss what the programs actually help with, where companies get tripped up, investor misconceptions, reimbursement expectations, and why “breakthrough” definitely does not mean “easy.”

They also cover:

• The 2025 CDRH Annual Report

• FDA staffing and communication challenges

• Whether CDRH News is finally back from the dead

• Upcoming Real-World Evidence initiatives

• FDA hierarchy, appeals, and how major regulatory decisions can change at the highest levels

• Bald eagles, hummingbirds, ravens, and aggressively competitive birds of prey

Plus: terrible jokes, medtech optimism, and a surprisingly deep conversation about regulatory nuance.

Key Topics Covered

• Amferia Wound Dressing De Novo

• Optune Pax PMA for pancreatic cancer

• Tumor Treating Fields technology

• FDA Breakthrough Device Designation

• TAP (Total Product Life Cycle Advisory Program)

• Reimbursement and investor expectations

• FDA appeals and hierarchy

• 2025 CDRH Annual Report

• CDRH News revival

• Real-World Evidence Town Hall

• General Wellness guidance updates