ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA’s “reduction in force” layoffs finalized; US digital health authorization numbers; CMS coverage determinations and payment rules; Capitol Hill updates; medtech guides from Africa and Singapore; EU news; dates to remember; and more.
FDA Picks
Layoffs finalized, digital numbers, and more:
CDRH separations. Many FDA employees placed on administrative leave back in April received terse final separation notices on July 14. Exactly how many CDRH staff ultimately were cut remains unclear, as the agency has quietly reinstated an array of previously dismissed employees over the past several months. (For more details see, “FDA Staffers are Hit With Separation Notices.”)
FDA’s digital health work. The US agency has authorized more than 1,200 artificial intelligence-enabled devices, more than 200 sensor-based digital health technologies (DHTs), and more than 90 augmented/virtual reality (AR/VR) devices as of May 31, according to July 10-updated data on FDA’s website. The agency has been tracking AI-enabled and AR/VR device authorizations for the past several years based on information available in public summaries. But this is the first time it updated its lists since the new administration took over in January. This is also the first listing of sensor-based DHTs, which are wearable monitoring devices, including continuous glucose monitoring systems and other clinical-grade health trackers such as various heart rhythm monitors built into the Apple Watch. FDA noted with its updated list of AI devices that it planned to “explore methods” to identify devices that incorporate large language models (LLMs) and related advanced AI technologies, although the agency has yet to authorize such a device. (See “LLMs Meet Medtech Regs: The First AI Chatbot Medical Devices, and Questions Ahead,” Market Pathways, July 10, 2025.)
