The FDA has granted Second Sight Medical an Expedited Access Pathway designation for its new visual prosthesis system designed to restore sight to patients who are completely blind.
Second Sight
Brain Implant Launching Clinical Trial to Restore Vision to Patients
The device, called the Orion, is a modified version of Second Sight’s current Argus II bionic eye, which involves a pair of glasses outfitted with a camera and an external processor. The U.S. Food and Drug Administration has granted the company a conditional approval for a small study involving five patients at two sites, Baylor College of Medicine and the University of California, Los Angeles. Second Sight still needs to conduct further testing of the device and answer certain questions before starting the trial but hopes to begin enrolling patients in October and do its first implant by the end of the year.
‘Bionic Eye’ Allows Mother to See Her Youngest Child for First Time
A Quebec mother of four can partially see again thanks to a “bionic eye” that was implanted in March in the first such operation of its kind in the province.
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