Brain implant for some blind people shows benefits of FDA ’s Breakthrough Device Program

Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program. Eligible technologies must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives. The Orion is a brain implant for patients with blindness caused by damage to the optic nerve. With the designation, 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. These 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. And, when the development and evaluation of...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news