Home Health, Human Factors & RAPID
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo tackle another busy week in MedTech, exploring how FDA policy is increasingly supporting a future where more medical devices move from hospitals into patients' homes.
The episode opens with a deeper look at CaRi-Heart, Caristo Diagnostics' recently classified AI-powered cardiovascular risk prediction software. Allison and Michael discuss the newly released De Novo classification order, including FDA's use of post-market performance management as a special control and what it could mean for future AI-enabled predictive devices.
The conversation then shifts to FDA and CMS's formally proposed RAPID coverage pathway, examining how earlier coordination between regulators and payers could streamline reimbursement planning for Breakthrough Devices while raising new questions about IDE studies and Medicare enrollment requirements.
The hosts also discuss FDA's updated guidance for over-the-counter medical devices, the growing importance of human factors engineering, and why more companies should be thinking about how their devices can safely migrate from clinical settings into patients' homes. Along the way, they highlight FDA's proposal to down-classify digital breast tomosynthesis (3D mammography), preview the upcoming GRAIL Galleri PMA advisory panel, and spotlight FDA's Patient and Caregiver Connection program as an underutilized resource for incorporating patient perspectives into regulatory decision-making.
Additional topics include:
Regulatory Science Innovations Catalyzing Medical Device Development public meeting, co-sponsored with MDIC
As always, the conversation mixes practical regulatory strategy with real-world MedTech experience, a healthy appreciation for patient-centered innovation, and enough terrible jokes to keep everyone humble.
