The first official episode of Trying to Keep Up (TTKU) is here.

Allison Komiyama and Michael Nilo kick things off by diving into the FDA news, guidance changes, and medtech industry shifts already making waves in 2026. The conversation explores what regulatory and clinical teams should actually pay attention to—without spiraling into doomscroll mode.

As always, the goal is simple: help medtech teams stay informed without losing their minds.

Plus: jokes about aging, running for five straight days, and throwing your back out reaching for toilet paper.

Key Topics Covered

• Infection Control Branch confusion and changes
• CDS Guidance updates
• General Wellness Guidance updates
• Removal of the SaMD guidance
• TEMPO / ACCESS initiatives
• FDA reviewer performance impacts
• Last-minute labeling change requests
• Early 2026 FDA and medtech trends
• Recent approvals since January 1
• Remembering Mike Fogarty

Connect

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

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