FDA clears Hyperfine AI-powered brain imaging software
July 17, 2024
Hyperfine (Nasdaq:HYPR) announced today that the FDA cleared its ninth-generation AI-powered Swoop system software.
Hyperfine (Nasdaq:HYPR) announced today that the FDA cleared its ninth-generation AI-powered Swoop system software.
Bern & Boston, US, June 24th, 2024 – Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today announced the registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) of 4 devices.
Powered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions
Leuko, founded by a research team at MIT, is giving doctors a noninvasive way to monitor cancer patients’ health during chemotherapy — no blood tests needed.
Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.
Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next generation AI-powered VIO™ Skin Platform (VIO)
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.