|Second Sight's Argus II Retinal Prosthesis System, the world's first bionic eye, was approved for a humanitarian device exemption by FDA in February.|
Twenty years of research, investment, and patience paid off for Second Sight Medical Products Inc. when FDA approved its Argus II Retinal Prosthesis System, the world’s first bionic eye, in February under the humanitarian device exemption.
The Argus II features a head-mounted digital camera that communicates with an implant attached to the eye. It is aimed at people affected by retinitis pigementosa, a degenerative retinal disease that often results in complete blindness in both eyes.
The company received a good chunk of its $100 million in private funding from medtech entrepreneur Alfred Mann and even managed to snag an investment from a venture capital firm—not an easy task for a developer of bionic prosthetics, which take notoriously long to bring to market. This summer, CMS approved the Argus II for payment in both inpatient and outpatient care settings, paving the way for Medicare beneficiaries to have access the device.