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    Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis

    The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis...

    Digital X-ray company Nanox scores first FDA clearance

    The company's device promises to change the way medical imaging is used and make it much more widely available by cutting the cost. Israeli imaging...

    FDA grants Oxehealth Vital Signs De Novo clearance; Oxehealth launches in the US

    Vision-based patient monitoring and management company will focus on skilled nursing facilities, where its technology service can help clinicians deliver safer, higher quality and...

    Caristo Diagnostics announces EU approval for AI technology that can predict heart attacks years in advance

    Research funded by us has led to EU-approved artificial intelligence (AI) technology that can identify people at high risk of a fatal heart attack...

    FDA Grants Breakthrough Device Designation to Tempus’ Atrial Fibrillation ECG Analysis Platform, Developed in Collaboration With Geisinger

    Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough...

    GE Healthcare Gains FDA Clearance of New 3D Surgical Imaging

    GE Healthcare was granted FDA 510(k) clearance to market OEC 3D, a new surgical imaging system capable of 3D and 2D imaging. This new system combines...

    Medtronic secures CE mark for directional lead system for deep brain stimulation

    Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed...

    LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

    LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery...

    Boston Scientific receives FDA approval for TheraSphere device

    Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma...

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