Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.
WASHINGTON, May 2, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan’s De Novo request for BrainSee by the U.S. Food and Drug Administration (FDA).
Most antibiotics target metabolically active bacteria, but with artificial intelligence, researchers can efficiently screen compounds that are lethal to dormant microbes.
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
The CEO of Prenosis told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam
Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity.
Solution uses fully automated AI segmentation to generate inHEART’s digital twin of the heart with greater speed and efficiency
Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds.
Hologic (Nasdaq: HOLX)+
announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.