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    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...

    ONWARD Receives FDA Breakthrough Device Designation for ARC-IM for Blood Pressure and Trunk Control in Spinal Cord Injury

    ONWARD announced the Company has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for their ARC-IM platform for blood...

    LivaNova Brings the Conversation Back to Neuromodulation with New IDE

    LivaNova is developing the aura6000 System to treat obstructive sleep apnea. The device will be evaluated in the OSPREY RCT Trial. The study comes...

    Accuray Receives Shonin Approval for ClearRT™ Helical kVCT Imaging, CE Mark Expected by End of June; Expands Commercial Launch

    Accuray Incorporated (NASDAQ: ARAY) announced that has received CE Mark certification for its ClearRT™ helical fan-beam kVCT imaging capability. The Accuray-only ClearRT technology is now available...

    Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device

    Sofia® Q device features a miniaturized, AI-powered design Quidel plans initial release to professional and point-of-care segments with a goal of expansion to serve telemedicine and...

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