The UK National Audit Office is investigating Capita's delivery of the £239 million Civil Service Pension Scheme after key service levels were repeatedly missed, with the outsourcer having paid out £4…
Nabla Bio, an OpenAI-backed Massachusetts biotech company, said its JAM-2 model generated high-affinity antibody candidates against 26 targets and that it expects first-in-human trials of AI-designed …
A Show HN project called FDA offers AI agents temporary, session-scoped machine access with audit logs instead of standing SSH credentials. The tool grants permissions only for the duration of a sessi…
PiFl Labs removed a nested schema.org Product node from the JSON-LD on its multilingual public-safety recall pages after Google Search Console flagged nine invalid product-snippet URLs for missing off…
GPT-6 Astra led a new 71-task biopharma benchmark with a 70.4% mean score and fully passed 8 tasks, while GPT-6 Sol placed fifth at 54.3% and DeepSeek V4.1 Flash fourth at 57.0%, according to results …
Medical AI developers should select a single first regulatory claim — such as measuring a radiologist-selected pulmonary nodule on non-contrast chest CT — before funding validation, because each of fi…
Paradromics' first Connect-One study participant, a Michigan woman in her 60s with motor neuron disease, used the company's implanted Connexus brain-computer interface to generate real-time speech, an…
STAT's Health Tech newsletter reports on Epic's mortality model and Omada's future products, according to the newsletter's co-author Mario, who covers FDA regulation of artificial intelligence, Medica…
Stanford Medicine researchers published a Science paper describing a virtual biotech company composed of roughly 37,000 AI agents spanning the drug-development pipeline. Lead author Zhang and senior a…
STAT's Health Tech newsletter, co-authored by Mario Aguilar, covered a "Zocdoc for chatbots" concept and updates to Medicare's ACCESS program in its latest edition. The newsletter, published twice wee…
The FDA has authorized 1,524 AI-enabled medical devices as of August 2026, but zero of those clearances cover generative AI products designed to manage mental health conditions, even as federal agenci…
The FDA granted De Novo request DEN250044 to Powerful Medical for its STEMI AI ECG Model, known as the Queen of Hearts, on September 3, 2026, creating new product code SHS with a predetermined change …
The FDA cleared a Class II AI device, K232613, on February 28, 2024, whose indications for use define the regulated device as a command line software application running on Ubuntu 20.04.5 LTS via Dock…
A quality-management engineer working in a Class II medical device environment describes discovering that an AI feature in an eQMS had approved a CAPA closure without any written record of who authori…
The FDA expanded its approval of a Bayer lung cancer drug, according to STAT+. The same STAT+ brief notes regulators are working to keep pace with agentic medical AI and that the FDA launched a projec…
ARPA-H will invest $62.7 million to develop FDA-authorized AI agents for treating heart failure, announcing the first $33.7 million in awards to Atman Health, UpDoc, Tempus AI, Stanford University, Du…
Willette M. Crawford, a food science consultant and cofounder of Katalyst Agricultural Solutions, said AI is improving food safety by enabling faster, more targeted outbreak detection, and that the re…
Vitestro, a Dutch medical robotics company, has received U.S. Food and Drug Administration (FDA) clearance for its autonomous blood-drawing robot, which is set to launch in the United States. The devi…
The FDA approved daraxonrasib (Rasonque), a once-daily pill from Revolution Medicines for stage 4 pancreatic cancer, which nearly doubled median survival to 13.2 months from 6.7 months with chemothera…
Limbic Inc.'s generative AI-enabled medical device Unpacked, which delivers CBT-based treatment via a voice agent for depression, is on the U.S. market under the FDA's TEMPO pilot, marking the first s…