Tag: 510(k)
Heartvue’s cardiac MRI AI clears FDA with self-update built in
FDA clearance for Heartvue.Proton includes a PCCP that lets the cardiac MRI AI learn without refiling.
Tempus’s ECG-PH lands as third cleared heart AI tool
Tempus ECG-PH reads standard 12-lead tracings for signs of elevated pulmonary artery pressure.
Study finds almost no FDA-cleared AI devices tested on outcomes
A PLOS Digital Health study finds only three of 1,357 FDA-cleared AI devices were ever tested on patient outcomes.
Samsung’s Galaxy Ring wins first FDA nod for over-the-counter sleep apnea screening
Samsung's Galaxy Ring becomes the first over-the-counter smart ring cleared by the FDA to flag sleep apnea risk.