Coreline Soft said its artificial intelligence (AI)-powered coronary artery calcification automatic diagnostic solution, AVIEW CAC, has received 510(k) clearance from the U.S. FDA.
A 510(k)...
Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication.The FDA approved Tandem’s 510(k) application for...
US-based biotech Fractyl Health has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial...
Eko Health announced today that the FDA cleared its Low EF (ejection fraction) detection AI platform for its digital stethoscope.Using an Eko stethoscope, providers...
Baird Medical has received new Class III certificate for its ceramic thyroid ablation needle from China’s National Medical Products Administration (NMPA).
The certificate recognises the...
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can...
Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop.
The Liechtenstein-based...
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring.SleepStageML automatically stages sleep from electroencephalogram (EEG) signals...
SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance.Linköping, Sweden-based SyntheticMR said in a news release that...
