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    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...

    ABK Biomedical obtains breakthrough designation for microspheres device

    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...

    Monarch surgical robot earns regulatory approval in China

    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...

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