FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.
FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.
Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.
CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera intraocular lens.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy Jivi.
Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...
Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...
