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    Regulatory Approvals

    SonoMotion gains FDA clearance for Break Wave device to treat kidney stones

    SonoMotion has received the US Food and Drug Administration (FDA) 510(k) clearance for its Break Wave non-invasive kidney stone treatment device. The system employs low-pressure...

    mOm Incubators receives FDA clearance for portable incubator

    mOm Incubators Limited announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s mOm Essential Incubator, a first-of-its-kind...

    SurGenTec secures FDA clearance for ION-C Facet Fixation System

    SurGenTec, a medical device innovation company focused on advancing treatment options for orthopedic and spine surgery, announced FDA clearance of its ION-C Facet Fixation...

    iotaMotion gains paediatric FDA indication for cochlear implant robot

    Robotics company iotaMotion has received a paediatric indication expansion for its robotic-assisted iotaSOFT cochlear implant insertion system from the US Food and Drug Administration...

    Amplifi Vascular wins FDA breakthrough nod for vein dilation system

    Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System. The St. Louis-based company also picked up Category B assignment...

    Imricor wins FDA clearance for MRI-guided EP mapping catheter

    Minneapolis-based Imricor Medical Systems said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter. The 9 Fr. catheter is designed for use...

    Siemens Healthineers wins FDA nod for helium-free MRI system

    Siemens Healthineers announced that it received FDA clearance for its 70cm bore Magnetom Flow magnetic resonance imaging (MRI) platform. The 1.5T platform features a closed...

    Naox Technologies wins FDA clearance for earbud-based EEG

    Naox Technologies has received FDA 501(k) clearance for its wired electroencephelography (EEG) earphones, Naox Link. Paris-based Naox Technologies says it is taking its EEG sensors...

    Stereotaxis MAGiC cardiac ablation catheter wins FDA approval

    Stereotaxis has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be...
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