Regulatory Approvals

Trax Surgical received FDA 510(k) clearance to market its Linkt Compression Staple System. According to the Stoughton, Massachusetts-based orthopedic product development and distribution company, the...

Elucent Medical, a leading innovator in the field of guided surgical technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted...

RebrAIn, a pioneering France based medtech company, with commercial operations in Europe and the United States, announced the achievement of its CE certification under...

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...