CMS chat room gave tech firms access to officials, report says; device makers seek wider RAPID path; FDA grants pacemaker identifier; GPT-5 misreads images
Listen to this post
read by AI voices ยท all episodesTechnology and AI companies lobbied federal health officials for about a year in a 1,700-member Slack workspace run by the Centers for Medicare & Medicaid Services, KFF Health News reported Oct. 9.
Only a handful of the members were patient advocates, physicians or hospital representatives, according to the report, which drew on thousands of messages, meeting transcripts and recordings. Vendors in the workspace pushed for broader access to patients' records for vetted apps, and CMS officials indicated that apps the agency promotes would be prioritized for a new program paying for AI chatbot advice and wearable tracking, the outlet reported. CMS did not answer questions about whether the group complies with federal advisory committee law.
The weekend was quiet. Device makers pressed CMS to widen its proposed RAPID coverage pathway before comments close Oct. 13, the Food and Drug Administration granted a De Novo to a handheld identifier for implanted cardiac devices, and a study of GPT-5 found image misreadings and unreliable web search in real-world diagnosis.
- WatchRegulation Oct 9, 2026
CMS has not said how apps join its Medicare App Library or when a payment program for them would start, KFF Health News reported.
The workspace, opened in August 2025 by Amy Gleason, now chief product officer of CMS's Office of Health Technology and Products, counted Oura, Palantir and the venture firm 8VC among its members and only a handful of physicians, patient advocates or hospital representatives, the outlet reported. The FDA invited companies including Microsoft, Anthropic, OpenAI, Apple and Google through the workspace to a February listening session on conversational AI products that was not on its public calendar. CMS officials indicated that apps listed in the agency's Medicare App Library, which promotes about two dozen commercial apps, would be prioritized for a new program paying companies for AI chatbot advice or wearable tracking, according to the report. Joseph Daval, a former FDA lawyer now at Harvard Medical School, said the group resembles a federal advisory committee, which must be open to the public; Gleason called it an "open, voluntary technical collaboration," and the workspace's code of conduct says it is not an advisory committee. AMA chief executive John Whyte told the outlet some AI tools "aren't ready for primetime."Source: KFF Health News - ActRegulation Oct 9, 2026
Public comments on CMS's proposed RAPID coverage pathway for breakthrough devices are due Oct. 13, according to MedTech Dive.
AdvaMed, the medical device trade group, asked CMS and the FDA on Oct. 8 to widen eligibility for breakthrough-designated devices, let diagnostics take part, set firm timelines for national coverage determinations and protect technologies planned under earlier coverage pathways. RAPID, short for Regulatory Alignment for Predictable and Immediate Device, would propose Medicare coverage of some breakthrough devices on the day the FDA authorizes them; CMS expects about 40 devices would qualify now and about 20 more later, MedTech Dive reported. Under the proposal, Class II devices must join the FDA's Total Product Life Cycle Advisory Program to be eligible, and CMS does not plan to cover in vitro diagnostics through the pathway. "Medicare beneficiaries shouldn't have to wait for FDA-authorized breakthrough technologies," said Scott Whitaker, AdvaMed's chief executive.Sources: AdvaMed, MedTech Dive - FYIRegulation Oct 8, 2026The FDA granted De Novo authorization, the pathway for new low- to moderate-risk devices with no predicate, to the SmartRead system from BridgeSource Medical of Austin, Texas, MassDevice reported Oct. 8. The handheld device mimics the opening signals of each major manufacturer's programming wand, including Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort, and waits for the implant to answer, so emergency department clinicians can tell which programmer a patient's device needs. Development was supported by small business grants from the National Institute on Aging, including $3 million in commercialization funding, according to a co-founder. The report does not say whether the device uses AI and cites no clinical performance data.Source: MassDevice
- FYIEvidence Oct 9, 2026Researchers from the University of Pennsylvania, Stanford, Mayo Clinic, the National Library of Medicine and other institutions tested 10 GPT-5-based configurations, including agentic and web-search setups, on 161 clinician-validated cases that combined text and images, according to the paper published Oct. 9. The models used patient histories well and gave clear stepwise reasoning and plausible differential diagnoses, but misinterpreted images, and inconsistent web search sometimes lowered performance, the authors reported. Reliable multimodal diagnosis "depends more on transparent reasoning and high-quality inputs" than on aggressive retrieval or complex agentic workflows, the authors wrote. The article is an accepted version that may change before final publication.Source: npj Digital Medicine
- FYIMoney Oct 8, 2026Bridge Neurotech, a spinout of Forest Neurotech, launched Oct. 8 with $13.5 million to build noninvasive brain-computer interfaces that use ultrasound to detect blood-flow changes tied to neuron activity, with software decoding the signals as a proxy for intended thoughts or actions, MassDevice reported. The company will license Butterfly Network's ultrasound-on-chip platform under a multiyear deal with milestone payments; financial terms were not disclosed. The report describes the sensors as planned and cites no testing in people. Butterfly's licensing program now includes about a dozen partnerships.Source: MassDevice