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    FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system

    Jupiter Endovascular announced the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II...

    Femasys secures CE mark certification for FemVue MINI solution

    Biomedical company Femasys has secured CE mark certification and Health Canada approval for FemVue MINI, a compact solution for assessing fallopian tubes. Designed for in-office...

    Vitestro gains CE mark for autonomous blood drawing robot

    An autonomous blood drawing device developed by Dutch company Vitestro has become the first machine of its kind to be granted a CE mark...

    Renata Medical wins FDA nod for first-of-its-kind stent for young children

    Renata Medical shared the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the...

    FDA grants breakthrough status to M.scio telemetric pressure measurement system

    The US Food and Drug Administration (FDA) has granted breakthrough device designation for the M.scio system, a non-invasive, telemetric pressure measurement system aimed at...

    FDA approves electrical nerve stim tech from Neuros Medical

    Neuros Medical announced it received FDA approval for its Altius direct electrical nerve stimulation system. The FDA cleared Altius as an aid in the management...

    CereVasc wins FDA breakthrough nod for eShunt system

    CereVasc received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies...

    US FDA approves Resivant Medical’s tissue adhesive products

    The US Food and Drug Administration (FDA) has issued 510(k) clearance for Resivant Medical’s high-viscosity tissue adhesive products, Cutiva Topical Skin Adhesive and Cutiva...

    Stimvia plans to enter US neuromodulation market after MDR certification

    Stimvia is set to enter the multi-billion dollar neuromodulation market in the United States with its innovative URIS device. The Czech company says this...

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