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Swiss neurodevicemaker MindMaze and Mount Sinai Health System, a New York City-based academic medical system, have teamed to develop an at-home digital neurotherapeutic therapy program for acute and long-term recovery from a stroke or concussion. Read More
The FDA has granted Breakthrough Device designations for Avita Medical’s Recell System for soft tissue repair and vitiligo – a condition in which the skin loses its pigment. Read More
Allotrope Medical has received the FDA’s Safer Technologies Program (STeP) designation for its StimSite surgical device, which helps surgeons locate and identify the ureter during abdominal surgery, reducing post-surgery cystoscopy time. Read More
Neurotech Pharmaceuticals has announced positive phase 3 topline results from two trials evaluating its NT-501 eye implant for patients with macular telangiectasia type 2 (MacTel), which makes the results the first to show preservation of photoreceptors with a novel ophthalmic neuroprotectant therapy, according to the company. Read More
Sweden’s SciBase has teamed up with Johnson & Johnson (J&J) to develop an augmented intelligence (AI)-based screening tool to predict a common type of eczema, atopic dermatitis, in infants. Read More
Eye movement tracking technology developer RightEye got a Form 483 for lapses in its design controls, product handling and complaint procedures, among other deficiencies observed during a June 28 to July 8 FDA inspection of its Bethesda, Md., facility. Read More
Encore sets up a collection system with hospitals for the used robotic attachment and makes loaner instruments available during the remanufacturing process. Read More