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    Regulatory Approvals

    FDA Clears ReddyPort® Non-Invasive Ventilation Device

    ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation...

    MediView XR receives 510(k) clearance for AR surgical navigation platform

    The Ohio-based company's XR90 offering allows physicians to view a patient's anatomical structures in 3D for preoperative and intraoperative use. MediView XR, a medtech company...

    Spark Biomedical’s second-generation device, Sparrow® Ascent, Receives FDA Clearance for Opioid Withdrawal Relief in Adults

    This FDA-cleared wearable neuromodulation system offers game-changing access for patients to start the road to recovery without interruptions to daily living. Spark Biomedical, Inc., a...

    Koru Medical submits infusion system for FDA 510(k) clearance

    Koru Medical Systems (Nasdaq:KRMD) announced that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system...

    BIOTRONIK Receives FDA Approval For Next-Generation Family of Pacemakers

    BIOTRONIK  announced U.S. Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest...

    Abbott Receives FDA Approval for World’s First Dual Chamber Leadless Pacemaker

    Abbott's breakthrough technology enables the world's first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery Leadless pacemakers...

    FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities

    FEops announced its new release of FEops HEARTguide™, including an AI-based anatomical analysis of MSCT images for the pre-operative planning of structural heart interventions....

    USMI Receives FDA Approval for New Robotic Surgery Device – The Canady Flex RoboWrist™

    US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC, announced it has received FDA Approval for its...

    NDR Medical Technology Wins FDA 510(k) Clearance for its ANT-X Automated Robotic Device

    NDR Medical Technology has announced that the ANT-X has been granted FDA 510(k) clearance by the U.S. Food and Drug Administration (FDA). This clearance makes...
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