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.
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