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    Regulatory Approvals

    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...

    Spectrumedics’ IVL catheter gains EU CE mark

    Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR). Related: StimLabs...

    StimLabs announces FDA clearance of Theracor

    StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to...

    SleepRes wins FDA nod for CPAP alternative

    SleepRes announced that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep apnea (OSA). Kricket PAP is powered by the...

    FDA clears CMR Surgical’s Versius Plus robot

    CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...
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