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    HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

    HistoSonics, (www.histosonics.com), the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today that the U.S. Food and...

    Q’Apel Medical Secures U.S. Patent for its SelectFlex™ Technology

    Q’Apel Medical, Inc. has announced that the United States Patent & Trademark Office has granted the company U.S. Patent No. 11,123,522 covering important features of...

    Life Spine Announces FDA 510(k) Clearance for the ProLift® Micro Expandable Spacer System

    Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it...

    Organon Receives FDA Clearance for Technological Updates to the Jada® System, a Medical Device Intended to Control Postpartum Hemorrhage

    Organon (NYSE: OGN), a global women’s health company, announced clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological...

    SyncThink scores FDA clearance for AI system to aid concussion diagnosis

    The system uses virtual reality and an AI-backed tool. SyncThink landed FDA clearance for its digital AI-backed system, called the EYE-SYNC, to be used as...

    iotaMotion Announces FDA De Novo Request to Market its Robotic-Assisted Cochlear Implant Insertion System

    iotaMotion has announced FDA granted its De Novo classification request to market the iotaSOFT™ insertion system. iotaSOFT is the world’s first and only robotic-assisted insertion...

    Labcorp Receives FDA EUA for Combo COVID-19/Flu Home Collection Kit

    Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined...

    Siemens gets FDA clearance for ‘major’ improvement to CT imaging

    FDA has granted 510(k) clearance to a Siemens Healthineers' diagnostic imaging device designed to boost the spatial resolution of computed tomography while reducing the dose.The product, which FDA...

    Nanowear scores third FDA clearance for connected vest with remote monitoring

    Providers can use SimpleSense to remotely triage cardio, pulmonary and upper vascular patients. Nanowear, a remote diagnostics and smart clothing company, has added another Food...

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