Regulatory Approvals

RebrAIn secures MDR Certification for its OptimMRI Platform

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

VUNO’s cardiac arrest risk monitoring system gains EU and UK certification

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)...

Teal Health gains FDA approval for cervical cancer screening device

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...

OcuSciences gains FDA clearance on retinal health scanner

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 wins FDA nod for AI-enabled ultrasound device EchoMap

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 wins CE mark for bioresorbable PerQseal Elite device

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 announces FDA clearance of Dynamis Robotic Surgical System

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...

Epiminder’s implantable EEG system for epilepsy receives FDA authorisation

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 wins CE mark for minimally invasive glaucoma treatment device

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....
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