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    Regulatory Approvals

    Serenity Medical earns FDA HDE for cerebral venous stent

    Serenity Medical announced that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. Harrison, New York-based Serenity said approval makes River...

    Medtronic wins CE mark for OmniaSecure pacemaker lead

    Medtronic announced CE mark approval and the first commercial European implants for its OmniaSecure system. The OmniaSecure defibrillation lead connects to an implantable defibrillator. It...

    Anumana secures FDA clearance for ECG-AI algorithm

    Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled...

    Neurovalens receives EU MDR compliance for sleep insomnia device

    Northern Irish company Neurovalens has received the EU Medical Device Regulation (MDR) compliance for its prescribed insomnia device, Modius Sleep. This product is now approved...

    4DMedical receives CE Mark for CT:VQ, enabling EU launch

    4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ™ has received CE Mark certification for commercial use...

    Pixee Medical announces CE Mark for Knee+ NexSight

    Pixee Medical, a pioneer in Augmented Reality (AR) guidance for orthopedic surgery, announced it has received CE mark for Knee+ NexSight, its new AR-based...

    Meril secures CE mark for MISSO Surgical Robot

    Meril Life Sciences has secured CE marking for its MISSO robotic surgical system, a regulatory milestone bringing the platform into compliance with the stringent...

    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...
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