This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Alexia Haralambous to unpack a high-impact week in medtech regulatory activity. The team explores a newly cleared De Novo for eardrum bulging detection and why broader classifications matter for innovation. They discuss two major PMAs—including a neurostimulation system for sleep apnea and a transcatheter heart valve—highlighting clinical implications and regulatory strategy.  

The conversation also touches on emerging breakthrough devices (including voice-based diagnostics and rapid infection testing), FDA’s upcoming ReDI conference, and a notable reclassification for melanoma diagnostic tools. Throughout, the group connects regulatory decisions to real-world patient impact—especially the shift toward home-based care. 

Key Topics Covered

• De Novo clearance: TytoCare Insights for eardrum bulging detection 

• Why broad vs. narrow classifications matter 

• PMAs:  

  • aura6000™ system for obstructive sleep apnea 

  • Trilogy transcatheter heart valve system 

• Breakthrough devices: 

  • MeMed BV Flex (bacterial vs. viral test) 

  • Noah Labs voice-based heart failure detection 

• Growth of home-based diagnostics and telehealth integration 

• FDA ReDI conference preview 

• Reclassification of melanoma diagnostic devices (Class III → Class II) 

• Benefit-risk considerations across user populations 

• The evolving regulatory bar for innovation