The FDA has just granted approval to Second Sight Medical Products to embark on a human clinical study of its newest visual prosthesis system. Known as Orion, the device is a newer iteration of the Sylmar, California-based company’s successful Argus II retinal implant product.
The Argus II gained approval in 2013, and it restores certain visual capabilities to people who have blindness that is caused by the inherited retinal degenerative illness Retinitis Pigmentosa (RP). The Orion expands on this ability, boasting the potential to help treat nearly every form of profound blindness.
The FDA’s conditional approval will allow two American sites to test the device on a handful of patients, but additional device testing will be required to gain full approval. The company also has to address some outstanding questions that the FDA has about the product. The clinical trial sites have been identified as The University of California at Los Angeles and Baylor College of Medicine in Houston. Continue reading “FDA approved “Bionic Man” retinal implant to treat certain types of blindness… but there’s no spy vision capability (yet)”