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    Regulatory Approvals

    FDA clears HeartBeam’s at-home arrhythmia assessment tool

    HeartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia assessment tool up for...

    Resmed wins FDA clearance for AI-enabled personalized CPAP therapy device

    Resmed announced that it received FDA clearance for its Smart Comfort personalized therapy offering. San Diego–based Resmed calls Smart Comfort (which was submitted to the...

    Cardiawave secures CE mark for ultrasound aortic stenosis therapy

    French MedTech Cardiawave has gained an EU CE mark for its non-invasive ultrasound therapy (NIUT) Valvosoft, marking the first device of its kind available...

    Atraverse wins FDA clearance for left heart access device

    Atraverse Medical announced that it received FDA clearance for its fully integrated Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device....

    FDA clears Francis Medical’s water vapour ablation treatment for prostate cancer

    Francis Medical’s Vanquish device for treating intermediate-risk prostate cancer has been cleared by the US Food and Drug Administration (FDA). Vanquish is a transurethral, ultrasound...

    Artiria Medical wins CE Mark for SmartGUIDE 014 deflectable guidewire

    Artiria Medical, a Swiss innovator in neurovascular technologies, proudly announces that its SmartGUIDE 014 deflectable guidewire, a next-generation guidewire specifically developed for neurovascular interventions,...

    a2z Radiology AI receives FDA clearance for abdomen-pelvis CT device

    2z Radiology AI has secured approval from the US Food and Drug Administration (FDA) for its a2z-Unified-Triage, a multi-condition triage system for abdomen-pelvis CT...

    Ligence Heart receives FDA 510(k) clearance

    Ligence announces that its AI-powered echocardiography software, Ligence Heart, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Ligence Heart, is an AI-powered...

    iCardio.ai wins second FDA 510(k) clearance for CardioVision

    iCardio.ai announces FDA 510(k) Clearance for CardioVision. This is the company’s second FDA clearance. CardioVision can automatically detect aortic stenosis, a disease affecting 1.5M Americans...
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