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    Regulatory Approvals

    Five breakthrough device designations granted by the FDA in November

    FDA Breakthrough Device Designations made in November included a sleep apnoea treatment to rival the CPAP machine and a neurostimulation migraine treatment The previous month...

    AliveCor gets FDA clearance for algorithms to detect more cardiac conditions

    The startup, which has developed a portable ECG device, received clearance for algorithms to detect more cardiac conditions, such as premature contractions. As more companies...

    Braid Health gets FDA approval for AI-powered diagnostic platform

    Braid Health has made sure about FDA clearance for its AI-fueled diagnostic collaboration programming, improving diagnostic access and decreasing expenses for huge healthcare frameworks,...

    NICO.LAB ready to revolutionize U.S. stroke care following FDA clearance

    The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB’s artificial intelligence powered solution in stroke care. StrokeViewer enables physicians to provide...

    Armis Biopharma announces FDA 510(k) clearance for VeriFixx small bone implant

    VeriFixx is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time and...

    FDA approves Tissium’s vascular sealant application

    Tissium, a medtech company developing biomorphic programmable polymers for tissue reconstruction, has received approval from the U.S. Food and Drug Administration for its Investigational...

    Hologic gets CE mark for Genius digital diagnostics system

    The platform is designed to help cytotechnologists and pathologists detect pre-cancerous lesions and cancer cells in women Genius digital diagnostics system for cervical cancer...

    Nanowear Receives FDA 510(k) Clearance for SimpleSENSE

    SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor's visit. Nanowear www.nanowearinc.com,...
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