Regulatory Approvals

The US Food and Drug Administration (FDA) has granted clearance to ZimVie’s spinal fixation system, Vital, for use with BrainLAB’s surgical imaging, planning and navigation...

The US Food and Drug Administration (FDA) has cleared NeuroOne’s radiofrequency ablation system, with a rollout of the device expected by the company in...

Becton, Dickinson and Company (BD) has obtained 510(k) clearances from the US Food and Drug Administration (FDA) for its new fingertip blood collection device,...

Biospectal has obtained European CE MDR Class IIa medical device certification for its OptiBP optical fingertip blood pressure monitoring app. OptiBP is claimed to be...

(Image Credit: Business Wire) Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle.The Gainesville, Florida–based company described the...

ABK Biomedical has received breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its Eye90 microspheres Y90 radioembolisation device. This designation...

Johnson & Johnson MedTech’s Monarch platform and Monarch bronchoscope obtained regulatory approval in China. Approval makes Monarch the first minimally-invasive, robotic-assisted technology approved for peripheral lung...

ScandiDos, a provider of patient-specific quality assurance solutions, has attained certification under the European Union Medical Device Regulation (MDR) for its quality system and...

AWAK Technologies has obtained breakthrough device designation from the US Food and Drug Administration for its AI-enabled kidney disease progression prediction (KDPP) tool. The KDPP model helps...