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23andMe Holding Co. announced the Company has received a U.S. Food and Drug Administration 510 clearance to expand its existing BRCA1/BRCA2 Genetic Health Risk Report. The clearance allows 23andMe...
510 clearance will allow 23andMe to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, prostate and pancreatic cancer Many of these...
FDA published groundbreaking draft guidance concerning use of artificial intelligence machine learning in medical devices. FDA attempt to provide support for the development of safe and effective medical devices that use machine learning enabled device software functions
Advisers will consider the latest data on the safety and efficacy of mpox vaccinations, updates on the flu season and vaccination and pneumococcal vaccines.