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    Regulatory Approvals

    joimax® Receives FDA Clearance to Market EndoLIF® Delta-Cage and DoubleWedge-Cage in the USA

    German-based joimax®, the market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is excited to announce that it has received...

    Quantum Surgical Secures CE Mark Approval for its Epione® Medical Robot

    Quantum Surgical, an innovative medical robotics company, announces that it has recently obtained CE mark approval for Epione®, its robot designed for minimally invasive...

    FDA clears MiRus expandable lumbar system

    MiRus said it received FDA 510(k) clearance for its IO expandable lumbar interbody. Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in...

    Asensus Surgical nabs third FDA clearance of 2021, this time for upgraded AI tools for its Senhance robot

    With months still to go, Asensus Surgical has already scored a hat trick this year with a trio of FDA clearances for components of its...

    FDA approves first vagus nerve stimulation implant for stroke rehabilitation

    The FDA approved its first nerve stimulation device designed to help people suffering from the lasting effects of stroke to gradually regain control of...

    Fuse Medical, Inc. Announces FDA 510(k) Clearance of the Sterizo™

    Fuse Medical, Inc. (OTCPINK: FZMD) ("Fuse" or the "Company"), an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace,...

    Innovative Health Sciences Receives FDA Clearance for Insignis™ Subcutaneous Needle Sets

    Innovative Health Sciences, LLC (“IHS” or the “Company”) management announced that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. This regulatory...

    Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

     Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSet™ Reverse Shoulder...

    FDA grants breakthrough device designation to Impella ECP

    The US Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart pump. The designation means the...
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