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    Regulatory Approvals

    Beyond Air’s LungFit PH system gains European CE mark approval

    Beyond Air has gained CE mark approval for its LungFit PH system, permitting the marketing of the device within the European Union and other...

    Neo Medical’s spine care platform fully approved under EU Medical Device Regulation

    Neo Medical SA, a Swiss technology company specialising in spine surgery, announced the approval of its entire product portfolio under the European Union’s (EU)...

    PixCell Medical gains EU IVDR certification for complete blood count analyser

    Israel-based PixCell Medical has received a CE mark for HemoScreen, a complete blood count analyser (CBC), under the EU’s In Vitro Diagnostic Medical Devices...

    Distalmotion gains FDA De Novo approval for its Dexter surgical robot

    The U.S. Food and Drug Administration has granted Distalmotion De Novo approval to market its Dexter Surgical Robot for adult inguinal hernia repair. Distalmotion claims...

    Ultromics obtains FDA clearance for Cardiac Amyloidosis screening device

    Ultromics' EchoGo Amyloidosis, clinical AI for echocardiography with the potential to revolutionise early detection of Cardiac Amyloidosis according to the company, has received US...

    LifeSignals gains FDA approval for UbiqVue wearable biosensor

    California-based MedTech LifeSignals (formerly HMicro) has received 510(k) clearance from the US Food and Drug Administration (FDA) for the UbiqVue 2A multi-parameter system for...

    CorVent wins FDA clearance for Respond critical care ventilator

    CorVent Medical announced it received FDA 510(k) clearance for its Respond critical care ventilator system. The company designed Respond as a cost-effective option to deliver...

    Augmedics picks up FDA nod for new CT-Fluoro registration

    The FDA cleared the CT-to-fluoroscopy (CT-Fluoro) registration method for Augmedics'  Xvision Spine System. The device uses augmented reality to give surgeons “X-ray vision” during...

    BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech

    BrightHeart received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart. The Paris-based company designed its AI...
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