RAPID Pathways, Real-Time Trials, and Recalls
In this episode of Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Véronique Li (Exponent) to unpack a fast-moving week across the FDA and CMS.
The discussion starts with the newly announced RAPID pathway, which aims to accelerate Medicare coverage for eligible breakthrough devices. The team explores what this could mean for reimbursement timelines, review burden, and overall regulatory strategy—especially in the context of ongoing staffing constraints.
They also break down the FDA’s proposed real-time clinical trial (RTCT) pilot, which leverages AI and continuous data monitoring to improve efficiency and safety. While the concept shows promise, the group highlights key questions around implementation, protocol design, and statistical impact.
Additional topics include:
A near-even split between U.S. and OUS 510(k) submissions—and what’s driving it
Ongoing gaps in FDA transparency, including delays in De Novo summaries
The progression of an early alert into a Class I recall for a blood glucose monitoring device, with potential global impact
Increasing cybersecurity expectations and the challenges of SBOM standardization
New FDA communications, safety updates, and reclassification activity
As always, the episode blends practical regulatory insight with candid discussion on what’s working, what’s unclear, and what to watch next.
Tune in to stay current on the policies, trends, and real-world implications shaping MedTech today.
Links
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life-changing medical devices
MDR coding resources
Tips to Help Charge Medical Devices Safely and Avoid Overheating
MITRE cybersecurity papers
