The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
Cad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis ...
Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...
The FDA’s premarket approval green light spans one pan-cancer indication and five tumor-specific uses. JPM24: Caris crafts ...
As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...
NASHUA, N.H., Nov. 12, 2024 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven ...
Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ...
Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.
Artificial intelligence (AI) is revolutionizing health care, from diagnostics to patient care, but regulation is struggling ...
As of August 2024, the FDA has greenlit a staggering 950 AI– and ML-enabled medical devices. With the surge of connected ...
Ravi B Parikh, MD, MPP discusses the current and future use of artificial intelligence (AI) in the greater US health care ...