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    Regulatory Approvals

    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...

    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...

    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...

    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...

    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...

    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....

    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...

    Medtronic bags FDA approval for Vanta implantable neurostimulator

    Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug...

    Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

    Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication

    Latest articles

    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.,...

    Pear Therapeutics to Go Public in Roughly $1.6 Billion SPAC Deal

    The digital health company’s combination with Thimble Point Acquisition to raise about $400 million in gross proceeds Pear Therapeutics,...

    Quanta Raises $245 Million to Accelerate Commercialization of its SC+ Portable Hemodialysis System

    Largest-ever private funding round for a dialysis device company Quanta Dialysis Technologies Ltd (“Quanta”...

    AI drug discovery start-up Insilico raises more than $255m

    Hong Kong-based company Insilico Medicine, which uses artificial intelligence (AI) for drug discovery and development, has raised $255 million in a new...
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