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CI22M (Nucleus 22) implant received FDA approval in 1985, making it the first FDA-approved multi-channel cochlear implant. [18] [19] [20] While first approved for postlingually deaf adults, [21] its FDA approval expanded to people ages two and up in 1990 after clinical trials on children. [22] [23] [24] [25]
The Argus II retinal implant, manufactured by Second Sight Medical Products received market approval in the US in Feb 2013 and in Europe in Feb 2011, becoming the first approved implant. [6] The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities.
The second version, the Argus II, was designed to be smaller and easier to implant, and was co-invented by Mark Humayun of the USC Eye Institute, who had been involved in the clinical testing of the Argus I. [12] [11] The Argus II was first tested in Mexico in 2006, and then a 30-person clinical trial was conducted in 10 medical centers across ...
The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. The experimental device, known as Blindsight, "will enable even ...
Premia Spine received FDA approval to start an IDE trial of the TOPS System with 300 to 500 patients across up to 40 U.S. centers, randomizing participants into TOPS (67%) or fusion (33%) arms. The trial aims to compare the efficacy of TOPS versus TLIF in stabilizing one lumbar level (L2-L5) after decompression in patients with moderate lumbar ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
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