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    Vaporox Announces FDA Clearance for Its Next Generation Wound Care Medical Device

    Vaporox, a Denver based medical device company, has received clearance from the US Food and Drug Administration for its next generation VHT-200 medical device...

    NeuroRPM obtains FDA 510(k) for Parkinson’s monitoring on Apple Watch

    The AI-powered app allows for remote monitoring of common Parkinson's disease symptoms such as bradykinesia, tremor and dyskinesia via an Apple Watch. Digital health technology...

    Roundup: Lunit gets new CE mark for AI DBT solution and more briefs

    Also, Jolly Good has collaborated with Brigham and Women's Hospital to create medical education VR content. Lunit obtains new CE mark for AI DBT solution South...

    CORRECTING and REPLACING Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm

    New artificial intelligence algorithm flags and triages suspected abdominal aortic aneurysms Fourth paragraph, first sentence of release should read: Viz AAA uses artificial intelligence to...

    SurgVision announces that it has received 510(k) clearance from the U.S. Food and Drug Administration for the EXPLORER AIR® II

    SurgVision, a high-tech company developing pioneering solutions for fluorescence-guided surgical and interventional oncology, part of the Bracco Group, announces that it has received 510(k)...

    BD’s diagnostic test for infectious vaginitis gets 510(k) clearance

    Using BD's molecular diagnostic platform, the BD Vaginal Panel detects the three most common infectious causes of vaginitis. Becton, Dickinson and Company (BD) has secured 510(k) clearance...

    Prolira Announces FDA Clearance of the DeltaScan® Brain State Monitor for Detecting Acute Encephalopathy (Acute Brain Failure), a Condition Affecting Millions of Hospitalized Patients...

    Acute brain failure costs the US healthcare system $164 billion annually1 – rivaling the cost of care for heart disease and diabetes2 DeltaScan is the world's first bedside...

    TytoCare receives FDA 510(k) for wheeze detection software

    TytoCare receives FDA 510(k) for wheeze detection software Virtual primary care company TytoCare received FDA 510(k) clearance for clinical decision support software that analyzes lung sounds for...

    Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

    Pivotal study expected to be completed by year-end 2023 and set the stage for commercialization of PerQseal® system for large hole vessel closure Company announces €30...

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