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    Viz.ai sets its sights across the pond with CE mark for stroke-detecting AI

    With a recent influx of more than $70 million in a series C financing and, now, a shiny new CE mark for its stroke-spotting...

    Via Surgical Receives FDA Clearance for Industry’s First Orthopedic Suture-Based Fixation System

    The TissueTak™* tendon anchor is the first closed-loop suture based fixation for soft tissue to soft tissue repair of certain types of injuries, designed...

    Penumbra Wins FDA Clearance for RED 62 Reperfusion Catheter

    Penumbra, a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial availability of the...

    Axonics® Files PMA Supplement with the FDA for Non-Rechargeable Implantable Sacral Neurostimulator

    Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction,...

    Oticon Medical Announces FDA Premarket Approval for Neuro Cochlear Implant System to Treat Severe to Profound Sensorineural Hearing Loss

    Innovative System Will Expand Oticon Medical’s Proven Expertise in Cochlear Implantation to US Market Oticon Medical today announced that the US Food and Drug Administration...

    New View Surgical, Inc. Announces FDA Clearance of its VisionPort™ System for Minimally Invasive Surgery

    The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system New View Surgical, Inc., a medical device company developing proprietary imaging and access technologies for...

    Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

    Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical...

    NeuraLace ties up FDA clearance for chronic pain-relieving nerve stimulation device

    While most options for chronic pain relief rely on either invasive implanted devices or opioids and other highly addictive drugs, NeuraLace Medical’s entry in...

    Elekta radiotherapy system designed for changing cancer landscape now available for U.S. patients

    Elekta Harmony linear accelerator cleared by U.S. Food and Drug Administration Elekta (EKTA-B.ST) announced todaythat its Elekta Harmony* radiation therapy system recently received U.S. FDA...

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