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    Regulatory Approvals

    DeepSight receives first FDA clearance for NeedleVue LC1 Ultrasound System

    DeepSight Technology announced it received FDA 510(k) clearance for its NeedleVue LC1 ultrasound system. The company said clearance marks an important step forward in the...

    FDA grants investigational device exemption to Myra Vision’s Calibreye

    Myra Vision announced that it received FDA investigational device exemption (IDE) approval for its Calibreye system. The Shifamed portfolio company can now initiate its ADAPT...

    Instylla earns FDA premarket nod for hydrogel embolic system

    Instylla received FDA premarket approval (PMA) for its flagship Embrace hydrogel embolic system (HES). The Bedford, Massachusetts-based company received approval for Embrace for the embolization...

    Nyxoah wins FDA approval for sleep apnea neuromod system

    Nyxoah received FDA approval for its Genio neuromodulation device for treating sleep apnea. Genio utilises an implanted electrode around the hypoglossal nerve, stimulating the tongue...

    Pulsecare gets regulatory nod for nanosecond PFA in China

    Pulsecare Medical announced that Chinese regulatory authorities granted marketing approval for its pulsed field ablation technology. Shenzhen, China–based Pulsecare develops the NxPFA nanosecond PFA system....

    SetPoint Medical gets FDA nod for neuromod that treats arthritis

    SetPoint Medical announced the FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA). The first-of-its-kind device treats adults with moderate-to-severe RA not...

    New implant enabling women to access hip resurfacing surgery awarded CE mark

    A new style of hip implant from Embody Orthopaedic that enables women to have a type of hip surgery previously only suitable for men,...

    Stereotaxis wins FDA clearance for diagnostic mapping catheter

    Stereotaxis has received US Food and Drug Administration (FDA) clearance for MAGiC Sweep, an electrophysiology (EP) catheter. Shares in the company rose by 10.66% from...

    CARMAT receives MDR CE marking for Aeson artificial heart

    CARMAT, designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular...
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