FDA News

FDA grants expedited access for Orion prosthesis system

The FDA has granted the Orion Cortical Visual Prosthesis System an Expedited Access Pathway, which is given to select medical devices indicated for the treatment of life-threatening or irreversibly debilitating diseases/conditions, according to a press release from Second Sight Medical Products.

The Orion system converts images captured by a small video camera mounted on a patient’s glasses into a series of small electrical pulses. These impulses are transmitted to electrodes implanted on the visual cortex and allow for the perception of patterns of light. The system has the potential to restore vision to people who are completely blind.

This designation allows for the Orion device to have priority review and a greater reliance on postmarket vs. premarket data collection.

“FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options,” Robert Greenberg, MD, PhD, chairman of Second Sight, said in the release. “We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”

 

 

 

The FDA has granted the Orion Cortical Visual Prosthesis System an Expedited Access Pathway, which is given to select medical devices indicated for the treatment of life-threatening or irreversibly debilitating diseases/conditions, according to a press release from Second Sight Medical Products.

The Orion system converts images captured by a small video camera mounted on a patient’s glasses into a series of small electrical pulses. These impulses are transmitted to electrodes implanted on the visual cortex and allow for the perception of patterns of light. The system has the potential to restore vision to people who are completely blind.

This designation allows for the Orion device to have priority review and a greater reliance on postmarket vs. premarket data collection.

“FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options,” Robert Greenberg, MD, PhD, chairman of Second Sight, said in the release. “We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”