This week on Trying to Keep Up, Allison and Michael unpack a busy stretch across the FDA and medtech landscape. From new real-world evidence (RWE) examples and patient preference guidance to hiring insights and TAP program expansion, the conversation blends regulatory updates with practical perspective. They also highlight global innovation and share candid takes on FDA culture, communication, and what it really takes to “keep up.”

Links:

• OxyCare Uganda (Children’s Prize winner)
• FDA ReDI Conference (May 19-20, 2026)
• Real-World Evidence at FDA
• RWE FDA Voices Blog
• FDA's TAP Program Details
• Neurotech Conference 2026
• FDA's LinkedIn
• FDA's YouTube
• Exemptions from Premarket Notification: Class II Medical Devices
• Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer

Connect

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

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