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Although counterfeit devices may meet the definition of a “device,” the FDA will not be treating them as such, the agency says in a final guidance released yesterday. Read More
The FDA’s Ophthalmic Devices Panel met Thursday and reached consensus that unfilled/empty eye cup and “droptainer” ophthalmic devices — currently unclassified — should be considered Class I with general controls, as recommended by the FDA. Read More
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
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