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    Regulatory Approvals

    BrioHealth gets conditional FDA nod for pediatric ventricular assist device study

    BrioHealth announced that it received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device (VAD) in pediatric patients. Burlington, Massachusetts–based BrioHealth...

    Xeltis gains EU CE mark on positive trial data for vascular access graft

    Xeltis has gained a European CE mark for aXess, with 12-month pivotal data of the vascular access graft for haemodialysis demonstrating strong and higher...

    Corify Care picks up FDA nod for cardiac mapping tech

    Corify Care announced that it received FDA clearance for its Acorys imageless, non-invasive cardiac mapping platform. Madrid-based Corify designed its platform to provide a global,...

    AliveCor wins CE mark for 12-lead ECG

    AliveCor announced that it received CE mark for its Kardia 12L electrocardiogram (ECG) system. Mountain View, California-based AliveCor describes it as the world’s first AI-powered,...

    ProSomnus gets FDA nod for latest sleep apnea therapy device

    ProSomnus announced that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device. San Francisco–based ProSomnus says its clearance marks the...

    Adagio Medical wins FDA IDE to expand ventricular ablation study

    Adagio Medical announced that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial. FULCRUM-VT evaluates the company’s vCLAS cryoablation technology for treating...

    Anumana receives FDA clearance for ECG-AI Cardiac Amyloidosis algorithm, using a standard 12-Lead ECG

    Anumana, a leader in cardiovascular AI, announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI algorithm for cardiac amyloidosis (CA) – the...

    CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

    CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation...

    FDA grants 510(k) clearance for Allevion Medical’s Vantage system

    Allevion Medical has secured the US Food and Drug Administration (FDA) 510(k) clearance for Vantage, a fully disposable and sterile system intended to simplify...
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