FDA Grants Breakthrough Device Designation to ReVision Implant Visual Cortex Prosthesis

Belgian neurotechnology startup ReVision Implant has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its visual cortical prosthesis, Occular. The authorization lays the groundwork for first-in-human clinical trials.

The Occular system is designed to restore functional vision in people with severe blindness, including patients whose condition cannot be treated with retinal implants or optic nerve therapies. Unlike most experimental vision-restoration technologies, which rely on stimulating the retina, the Occular system interfaces directly with the brain’s visual cortex, enabling it to bypass damage to the eye or optic nerve.

“While cochlear implants have transformed treatment for hearing loss, there is still no widely available neuroprosthetic solution for restoring vision,” ReVision Implant CEO Frederik Ceyssens stated. “Our aim is to provide people living with severe blindness with functional vision that improves independence and quality of life.”

Occular uses a miniature camera mounted on a wireless headset to capture visual information. This data is transmitted to a brain implant that stimulates neurons in patterns interpreted by the brain as points of light. These signals combine to form simple visual representations that may help users identify objects and navigate their surroundings.

Engineers began developing the technology in 2020. Since then, the system has undergone extensive preclinical testing, including long-term animal studies lasting more than two years.

The FDA’s Breakthrough Device designation will allow ReVision Implant to collect early feedback on its regulatory roadmaps, data, and clinical trial protocols; it also grants the company access to the FDA’s Total Product Life-Cycle Advisory Program (TAP) Pilot.

A first short-term clinical trial during a scheduled brain surgery is currently scheduled for October. The company expects to begin early-stage human clinical trials in blind volunteers as soon as summer 2027, subject to regulatory approvals.

Globally, tens of millions of people live reportedly with severe vision loss, with many having conditions that cannot be treated using current surgical or pharmaceutical approaches. Since the Occular implant directly stimulates the visual cortex, the technology may be suitable for patients with various blindness causes, including retinal degeneration and optic nerve damage.

If clinical trials are successful, ReVision Implant executives are confident the system could benefit numerous patients with untreatable blindness—about 650,000 in the United States and the European Union combined.

ReVision Implant emerged from extensive research in high-resolution brain-computer interfacing. Its breakthrough lies in the ability to implant hundreds or even thousands of durable microelectrodes into the brain with minimal tissue disruption. In 2020, Ceyssens resigned his position at KU Leuven to focus fully on applying this knowledge to an unmet medical need: a well-functioning visual prosthesis for blind people. Since then, ReVision has made significant advancements in its technology and achieved successful animal testing results.