Brain Implant for Blind People Shows Benefits of FDA’s Breakthrough Device Program

The FDA’s Breakthrough Devices Program is beginning to show important results for patients, according to Malvina Eydelman, director of CDER’s Division of Ophthalmic, and Ear, Nose, and Throat Devices, and she cited Second Sight Medical Products’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program, as an example.

Second Sight qualified for interactive and timely communication with FDA, even before the Sylmar, Calif., company embarked on a clinical trial to study the device in patients.

The early interactions resulted in the development of a flexible study design, review team support, and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently, Eydelman said, in an FDA blog.