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    Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants

    Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that...

    FDA issues 510(k) clearance for twiist insulin system

    DEKA Research & Development has received 510(k) clearance from the US Food and Drug Administration (FDA) for the twiist automated insulin delivery (AID) system. The...

    FDA clears first over-the-counter wearable glucose tracker, with Dexcom’s Stelo

    The FDA has cleared its first over-the-counter wearable blood sugar tracker, with Dexcom’s slimmed-down Stelo continuous glucose monitor. Related: Orthobond wins FDA de novo approval...

    Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications

    Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical...

    SpineX eyes FDA submission as neurogenic bladder trial hits milestone

    SpineX has closed recruitment for a clinical study investigating its neuromodulation device to treat urinary incontinence. Data from the trial, which began in May 2022,...

    Spirair receives FDA clearance for SeptAlign system in NSD correction

    Spirair has secured 510(k) clearance for its SeptAlign system from the US Food and Drug Administration (FDA) for its use in the mechanical correction...

    FDA approves Symani surgical robot platform from Medical Microinstruments

    Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform.Clearance covers soft tissue manipulation to perform microsurgery....

    Neurovalens wins FDA nod for anxiety-treating neuromod device, raises $2.65M

    Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million.Belfast, Northern Ireland-based Neurovalens designed...

    Kelyniam and Finceramica announce FDA clearance for NEOS system

    Kelyniam Global and Finceramica Faenza have announced the Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system to...

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