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    Modular Medical seeks FDA 510(k) clearance for MODD1 insulin pump

    US-based insulin delivery technology company Modular Medical has submitted its next-generation MODD1 insulin pump to the US Food and Drug Administration (FDA) for 510(k)...

    Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2

    Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft...

    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,...

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