Regulatory Approvals

Sonavex announced that it received FDA 510(k) clearance for its AI-enabled EchoMap device with 3D ultrasound capabilities. EchoMap uses 3D ultrasound and AI algorithms to...

Vivasure Medical has received CE mark approval for its PerQseal Elite vascular closure system, providing a new bioresorbable option for percutaneous vessel closure. Vivasure’s device...

LEM Surgical, a developer of advanced robotic technologies for hard tissue surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted...

Australia-based company Epiminder has received Food and Drug Administration (FDA) authorisation through the De Novo classification for its implantable continuous electroencephalogram (EEG) monitoring system...

Sanoculis received CE mark for its MINT (minimally invasive nasal trabeculostomy) product. MINT, a stent-free platform, helps treat adult patients undergoing glaucoma angle surgery....

The US Food and Drug Administration (FDA) has cleared LUMA Vision’s Verafeye catheter-based imaging system. Verafeye is a four-dimensional (4D), ultrasound-based cardiac visualisation and navigation...

EBR Systems announced that it received FDA approval for its wireless cardiac pacing device for heart failure. The FDA approved its WiSE cardiac resynchronization...

CeriBell received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm. Clarity detects electrographic seizures in patients ages one and older. The company says...

DESKi announced FDA clearance of HeartFocus, its AI-enabled heart exam software. Bordeaux, France–based DESKi says it only takes a few hours of training for any...