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    Asensus Surgical wins FDA nod for surgical robot use in urology

    Asensus Surgical received FDA 510(k) clearance for an expanded surgical robot indication. The Research Triangle Park, North Carolina-based company’s Senhance surgical system can now...

    Spryte’s nOCT technology secures breakthrough device designation

    Spryte Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its neuro-optical coherence tomography (nOCT) technology. Designed to revolutionise...

    eCential Robotics wins FDA clearance for spine navigation robot

    eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.Gières, France-based eCential Robotics designed the device as...

    Inspire sleep apnea therapy wins CE mark under the EU Medical Device Regulation

    Inspire Medical Systems announced its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation. Going into effect in 2021, the tighter...

    Restore Medical’s ContraBand device receives FDA’s breakthrough status

    Restore Medical has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its ContraBand system to treat left ventricle (LV) failure. The...

    Positrigo’s NeuroLF brain PET system receives FDA clearance in the US

    Positrigo, a Swiss based company developing nuclear medical imaging devices to advance functional brain imaging, has achieved a significant milestone with the U.S. Food...

    FDA clears Providence Medical’s CORUS PCSS in cervical spine surgery

    Providence Medical Technology has received clearance from the US Food and Drug Administration (FDA) for its CORUS Posterior Cervical Stabilization System (PCSS), designed to...

    Medical Microinstruments signs multiple distro deals, wins regulatory nods

    Medical Microinstruments announced it hit significant commercial milestones for its surgical robot across two continents. The company develops the Symani surgical robot system, which...

    FDA clears Orthofix Fitbone transport and lengthening system

    Orthofix received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device. The Lewisville, Texas–based company...

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