fda
FDA funds study on LLMs evaluating AI radiology reports
The FDA awarded Cognita Imaging $1.29M to test if large language models can evaluate AI radiology reports, addressing a key gap in…
Robotic surgery system gains CE mark for vaginal procedures
Intuitive Surgical’s da Vinci SP robotic system earns CE mark for vaginal procedures, expanding minimally invasive gynecologic surgery options in Europe.
Medicare now covers TAVR for some asymptomatic heart patients
Medicare now covers TAVR for asymptomatic patients with severe aortic stenosis, expanding access to life-saving valve replacement without symptoms.
FDA tightens human factors rules for medical devices
The FDA’s stricter human factors rules for medical devices now prioritize usability engineering as a core safety requirement, reshaping validation standards for
FDA’s generative AI strategy faces four key questions
Generative AI regulation takes center stage as the FDA unveils its strategy, tackling approval pathways, safety standards, industry uncertainty, and oversight.
FDA approves Rusfertide for erythrocytosis in polycythemia vera
FDA approves rusfertide (Mimrylo) for erythrocytosis, sparing polycythemia vera patients from painful phlebotomies. Read the latest medical news.
FDA Approves New Narcolepsy Treatment
FDA approves new narcolepsy treatment targeting orexin deficiency for narcolepsy type 1 patients.