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    Regulatory Approvals

    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...

    FDA clears ImageBiopsy Labs’ latest AI-powered Software for a comprehensive Set of Automated Measurements on Long Leg Radiographs

    ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for...

    MEDICAL IP Received US FDA 510(k) Clearance for DeepCatch, AI Software for Whole-Body Composition CT Quantification

    The world's first FDA cleared solution that automatically analyzes bone, muscle, visceral fat, subcutaneous fat, internal organ, and central nervous system in whole-body CT Validation...

    FDA clears Huma’s disease management platform

    The clearance allows the platform to host artificial intelligence algorithms that aid in disease risk prevention. It also expands the population that can be managed...

    FDA launches pilot programme governing oncology IVD tests

    The FDA also approve treatments requiring a companion IVD test even if a corresponding diagnostic has not yet received marketing authorisation. The US Food and...
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