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    Regulatory Approvals

    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...

    Eko picks up reimbursement win for AI heart disease detection platform

    Eko Health announced the American Medical Association issued a Category III CPT code for its Sensora platform. The newly issued CPT code goes into...

    Xeltis wins FDA breakthrough status, enrols first patient in pivotal trial

    Dutch company Xeltis shared that the US Food and Drug Administration (FDA) granted breakthrough device designation to its lead product, called aXess, which will...

    Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD

    Magstim announced that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use...

    Momentis Surgical wins FDA nod for second-gen surgical robot

    Momentis Surgical announced the FDA granted 510(k) clearance for its second-generation Anovo surgical robot. Last month, Anovo received clearance for use in single-site, abdominal...
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