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    Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

    Biorez received FDA 510(k) clearance to market two sizes of the BioBrace™ Implant. This new biocomposite soft tissue scaffold is intended to be used in a...

    Acutus Medical Announces CE Mark Approval for Suite of Next Generation EP Products in Europe

    Expanded and Product Portfolio Strengthens Offering in Access and Therapy Guidance Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the...

    Neuromodulation treatment for chronic migraine given CE mark

    Chordate Medical Holding AB, a Swedish medtech company, has developed and patented an innovative treatment method: K.O.S. The company's existing EC-certificate for K.O.S has...

    Orthofix Announces FDA Clearance of the OrthoNext Digital Platform for the JuniOrtho Plating System

    Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced expansion of its pediatric offerings with the U.S. Food...

    Gut health startup Viome gets breakthrough device designation for mRNA analysis tool

    Viome has adapted its technology to search for the presence of oral squamous cell carcinoma and oropharyngeal cancer in users’ saliva samples. Viome, maker of at-home...

    Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

    Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected...

    FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial

    RenovaCare, Inc., announced that its Investigational Device Exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This...

    EYEMATE System for Remote Glaucoma Management Obtains FDA Breakthrough Device Designation

    HANNOVER, Germany and SAN DIEGO, CA, April 28, 2021 / B3C newswire / -- Implandata Ophthalmic Products, a digital health company with offices in Germany...

    Pixee Medical Receives FDA Clearance for Knee+

    Pixee Medical received FDA 510(k) clearance to market its Knee+ AR computer assisted orthopedic solution. Knee+ is designed to help orthopedic surgeons perform surgeries better...

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