This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Hal Stowe to unpack a deceptively busy week at the FDA: HDE pathways, AI misuse in compliance, clinical transparency gaps, and shifting trust in the agency—plus implications for MedTech strategy.

Key Topics Covered

• River Stent System HDE and orphan pathway strategy
• HDE fundamentals: safety + probable benefit standard
• PMA Federal Register update and pediatric data expectations
• AI in quality systems and validation risks
• ClinicalTrials.gov reporting gaps and compliance challenges
• FDA trust trends and public perception gap
• Combination product complexity (device–drug integration)
• READI Home Innovation Challenge and home-based care
• NIH HEAL Initiative funding for device research
• eMDR system update and usability improvements
• Expanded FDA authority request and policy implications
• Post-market vs pre-market regulatory balance

Links

• Serenity Medical River™ Stent
• FDA eMDR Reporting System Update
• Federal Register Notice – PMA Data Collection
• FDA Reclassification Database
• FDA READI Home Innovation Challenge
• NIH HEAL Initiative
• FDA Commissioner’s Request to Congress

Stay Connected

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Hal Stowe | Eurofins Biopharma Services