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    Regulatory Approvals

    UltraSight receives FDA approval for AI-based cardiac ultrasound technology

    UltraSight receives FDA approval for AI-based cardiac ultrasound technology. UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac...

    Microbot Medical Announces First Steps to Advance CE Mark for Sales in Europe 

    Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit...

    Imperative Care Announces FDA Clearance of Zoom 88 Support, Designed to Bring the Benefits of Intracranial Access to More Stroke Patients

    Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, announced U.S. Food...

    Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval

    Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it...

    STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations

    Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide STORZ & BICKEL GmbH ("STORZ & BICKEL"), the...

    FDA Clears ReddyPort® Non-Invasive Ventilation Device

    ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation...

    MediView XR receives 510(k) clearance for AR surgical navigation platform

    The Ohio-based company's XR90 offering allows physicians to view a patient's anatomical structures in 3D for preoperative and intraoperative use. MediView XR, a medtech company...

    Spark Biomedical’s second-generation device, Sparrow® Ascent, Receives FDA Clearance for Opioid Withdrawal Relief in Adults

    This FDA-cleared wearable neuromodulation system offers game-changing access for patients to start the road to recovery without interruptions to daily living. Spark Biomedical, Inc., a...

    Koru Medical submits infusion system for FDA 510(k) clearance

    Koru Medical Systems (Nasdaq:KRMD) announced that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system...
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