Regulatory Approvals

Enspectra’s VIO System secures FDA 510(k) clearance

Enspectra Health has received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for VIO System, a non-invasive skin imaging technology. By combining...

iRhythm secures CE mark for Zio monitor and ZEUS system

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...

EndoSound secures FDA 510(k) approval for EndoSound Vision System

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...

Belkin Vision’s glaucoma laser receives 510(k) clearance from FDA

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...

ZimVie’s spinal fixation system secures FDA clearance with Brainlab’s platform

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...

NeuroOne secures FDA clearance for OneRF ablation system

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...

BD receives clearance for new blood collection device

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 obtains CE mark for blood pressure monitoring app

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...

Exactech wins clearance for new ankle surgery navigation system

(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...
1...596061...116Page 60 of 116

Latest articles