Regulatory Approvals

South Korean company VUNO’s Med-DeepCARS (DeepCARS) solution has secured CE MDR certification in the European Union (EU), along with the UK Conformity Assessed (UKCA)...

The US Food and Drug Administration (FDA) has secured approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer screening. This...

The US Food and Drug Administration (FDA) has cleared OcuSciences’ retinal health assessment device, OcuMet Beacon. The non-invasive device is indicated for ophthalmoscope scanning for...

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...