Regulatory Approvals

US-based medical equipment manufacturer iRhythm Technologies has received the CE mark for its next-generation long-term ambulatory cardiac monitor, Zio monitor ECG system. The Zio monitor...

US-based medical technology company EndoSound has received the US Food and Drug Administration (FDA) 510(k) approval for its EndoSound Vision System (EVS). The EVS is...

Israeli medical device company Belkin Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its glaucoma laser, the Eagle...

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...