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    Regulatory Approvals

    FDA clears Varian’s TrueBeam systems for low-dose radiation therapy

    Varian has received US Food and Drug Administration (FDA) clearance for its TrueBeam radiotherapy systems to use low-dose radiation therapy (LDRT) in adults with...

    JenaValve wins FDA nod for Trilogy heart valve system

    JenaValve announced that it received FDA premarket approval (PMA) for its Trilogy THV system. Trilogy, a transcatheter heart valve (THV) system, won approval for the...

    Nia Therapeutics wins FDA breakthrough nod for neuromod

    Nia Therapeutics announced that it received FDA breakthrough device designation for its Smart Neurostimulation System (SNS). The device won the breakthrough nod for the treatment...

    Perfuze wins FDA clearance for standalone aspiration catheter

    Perfuze announced that it received FDA 510(k) clearance for its Millipede88 aspiration catheter. Galway, Ireland-based Perfuze designed the catheter for rapid and complete clot removal...

    Endo Tools Therapeutics receives FDA 510(k) clearance for EZFuse

    Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for...

    Prodeon gets FDA clearance for BPH-treating nitinol implant

    Prodeon Medical announced that it received FDA 510(k) clearance for its Urocross expander system. Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology...

    KORU Medical Systems announces EU MDR Certification

    KORU Medical Systems, a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions,...

    Cairn Surgical announces FDA De Novo 510(k) submission for its BCL System

    Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced that it has submitted a De Novo...

    OncoPatch wins FDA nod for tumor-treating patch device

    OncoPatch announced that it received FDA 510(k) for its Oncopatch Surface brachytherapy system for treating localized tumors. The technology offers a distinct, patch-based approach to...
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