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    Regulatory Approvals

    NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

    NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir...

    FDA approves Tyber Medical’s Mini-Frag System extension

    Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an extension to its Mini-Frag System. The approval introduces additional...

    FDA Clears Magstim Transcranial Magnetic Stimulation System Horizon 3.0 with StimGuide Pro

    Magstim, the global leader in neuroscience research and treatment for mental health, has been awarded FDA clearance for the Horizon 3.0 with StimGuide Pro....

    Element Science Receives CE Mark & UKCA Mark for the Jewel Patch-Wearable Cardioverter Defibrillator

    Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, announced that it has received the European Union’s...

    Absolutions receives FDA breakthrough designation for abdominal wall closure device

    Absolutions Med has received breakthrough designation for an abdominal wall closure device that is intended to reduce the risk of hernia.The Food and Drug...

    Able Medical’s Valkyrie RIB System secures FDA clearance for thoracic repair

    Able Medical Devices has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its Valkyrie RIB System...

    CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study

    CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study...

    FDA clears SnoreLessNow mandibular advancement device

    SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring...

    FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR

    Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures...
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