BrightHeart earned its second FDA 510(k) clearance for updates to its BrightHeart platform, an AI-powered digital screening tool for congenital heart defects (CHDs).
GE HealthCare (Nasdaq: GEHC) announced today that it received FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL
FaceHeart Vitals™ is a video-based, contactless vital sign measurement SDK that can be integrated into devices such as smartphones seamlessly, providing heart rate, respiration rate, blood pressure and other vital sign readings in 50 seconds.
Edwards Lifesciences (NYSE: EW) announced today that it received FDA approval for its Sapien 3 TAVR for severe aortic stenosis (AS) without symptoms.
Intuitive (NASDAQ: ISRG)+
announced today that it received FDA clearance for a new indication for its da Vinci single port (SP) surgical robot.
Element Science announced today that it received FDA pre-market approval for its Jewel Patch wearable cardioverter defibrillator (WCD).
Neuralink said today on social media that it received FDA breakthrough device designation for treating individuals with severe speech impairment.
Teleflex (NYSE: TFX) announced today that it received FDA 510(k) clearance for expanded indications of its QuikClot Control+ hemostatic device.
Sonavex announced that it received FDA 510(k) clearance for its AI-enabled EchoMap device with 3D ultrasound capabilities.
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon.