Heartflow receives FDA clearance for updated plaque analysis platform
September 25, 2025
The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.
The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.
Biolinq announced today that it received FDA de novo clearance for its lead product, the Biolinq Shine wearable biosensor.
DENVER, Sept. 24, 2025 /PRNewswire/ — TSC Life announces FDA clearance of its moderate to high flow blood and fluid warmer, Fluido® AirGuard System, in the U.S.
Medtronic (NYSE: MDT)+
today reported the first patient treated with its Altaviva neuromodulation device for urge urinary incontinence.
SAN FRANCISCO, Sept. 23, 2025 /PRNewswire/ — Bunkerhill Health today announced it has received U.S. Food and Drug Administration (FDA) clearance for ECG-EF, an artificial intelligence algorithm that detects reduced left ventricular ejection fraction (LVEF), a key indicator of heart failure, using data from routine 12-lead electrocardiograms (ECGs).
YONGIN, South Korea, Sept. 23, 2025 /PRNewswire/ — Noul Co., Ltd. (CEO: David Lim), a medical AI company specializing in blood and cancer diagnostics, announced that FDA registration has been completed for its cervical cancer diagnostic cartridge miLab™ Cartridge CER and clearing agent SafeFix™ CER, both core components of the company’s cervical cancer diagnostic solution miLab™ CER.
The expanded clearance extends BioTraceIO360 beyond liver applications to kidney procedures, advancing Techsomed’s vision of a multi-organ, AI-driven image-guided therapy platform that standardises minimally invasive cancer care.
Picard Medical (NYSE:PMI) announced today that it expanded its IP portfolio with a new U.S. patent for its next-generation artificial heart.
Cionic announced today that the FDA granted clearance for its second-generation product, the Neural Sleeve 2.
Virtuoso Surgical announced today that it received FDA breakthrough device designation for bladder lesion removal with its surgical robot.