Tag: FDA
Fractyl’s one-time gut procedure cuts weight regain after GLP-1s
A single endoscopic procedure cut six-month weight regain to 5.1% from 8.2% with sham after patients stopped tirzepatide, Fractyl Health…
Tempus reads lung tumour slides to sort who needs which test
A Tempus panel squeezed above 80% sensitivity on all 12 lung cancer biomarkers using nothing but routine H&E slides.
Natera wins FDA breakthrough tag for a 12-cancer blood test
Natera's cell-free DNA screening assay earned FDA Breakthrough Device designation after the agency reviewed data across 12 cancer types.
Surgical robots get their own FDA playbook, open for comment
The agency wants comments by Nov. 24 on how robotic surgery makers should test, document and label their systems.
Glytec aims its insulin algorithm at newborns in the NICU
The designation covers newborns and infants under two, a population with no FDA-cleared insulin dosing software.
FDA backs LLM juries to grade AI-written radiology reports
A $1.29M FDA contract will test whether several language models, supervised by radiologists, can evaluate AI-generated reports across roughly a…
ARPA-H bets $62.7M on AI agents for heart failure care
The health research agency has named the teams that will build an autonomous clinical AI agent for patients living with…
FDA pilot lets generative AI health apps launch without premarket review
Cadence and Limbic are among four products accepted into the FDA's TEMPO pilot for release before authorization.