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    FDA OKs Neuspera’s iSNM for urinary urge incontinence

    Regulatory Approvals
    Neuspera Medical has obtained U.S. Food and Drug Administration (FDA) approval for its integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI). The iSNM system provides UUI patients an alternative to a traditional...

    FDA OKs Neuspera’s iSNM for urinary urge incontinence

    Regulatory Approvals
    Neuspera Medical has obtained U.S. Food and Drug Administration (FDA) approval for its integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI). The...

    FDA grants expanded clearance for Levita Magnetics surgical robot

    Regulatory Approvals
    Levita Magnetics announced that it received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system. The FDA granted 510(k) clearance for its Magnetic...

    ANACONDA Biomed wins CE Mark for ANA5 funnel catheter for stroke

    Regulatory Approvals
    ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark...

    Corvia Medical raises $55m to complete confirmatory heart shunt trial

    Funding
    Corvia Medical has raised $55m to complete an ongoing clinical trial of its atrial shunt system for heart failure. The US-based company’s trial began in...

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    Finance

    Funding

    Clinical Trials

    FineHeart can begin first-in-human LVAD trial of its FlowMaker device

    FineHeart announced French regulators gave it the green light to initiate a first-in-human heart device trial in France. The French National Agency for the Safety...

    NeuroPace reports one-year data on neuromodulation therapy for epilepsy

    NeuroPace announced preliminary one-year results from its Nautilus clinical study evaluating neuromodulation therapy for idiopathic generalised epilepsy (IGE). The company said the study met its...

    Inner Cosmos shares data for psychiatric BCI technology

    Inner Cosmos recently reported interim 36-month outcomes from a study of its psychiatric brain-computer interface technology. The company evaluated the safety and feasibility of...

    EnVVeno has first-in-human heart valve data, expects FDA decision this year

    EnVVeno Medical announced three-year outcomes for its heart valve that it aims to submit to the FDA this year. The company (formerly Hancock Jaffe)...

    Innovation

    Regulatory Approvals

    FDA OKs Neuspera’s iSNM for urinary urge incontinence

    Neuspera Medical has obtained U.S. Food and Drug Administration (FDA) approval for its integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI). The...

    FDA grants expanded clearance for Levita Magnetics surgical robot

    Levita Magnetics announced that it received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system. The FDA granted 510(k) clearance for its Magnetic...

    ANACONDA Biomed wins CE Mark for ANA5 funnel catheter for stroke

    ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark...

    Corvia Medical raises $55m to complete confirmatory heart shunt trial

    Corvia Medical has raised $55m to complete an ongoing clinical trial of its atrial shunt system for heart failure. The US-based company’s trial began in...

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