Belgian neurotechnology startup ReVision Implant has received Breakthrough Device designation from the FDA for its visual cortical prosthesis, Occular, clearing the way for first-in-human clinical trials.

The Occular system targets patients whose vision loss cannot be treated using existing approaches such as retinal implants or therapies targeting the optic nerve. Instead of stimulating the eye, the device interfaces directly with the brain’s visual cortex, bypassing damaged ocular structures.

According to ReVision, the Occular system uses a miniature camera mounted on a wireless headset to capture visual information from the user’s surroundings. The captured data is then transmitted to a brain implant, which stimulates neurons in the visual cortex in specific patterns. These patterns are interpreted by the brain as points of light, which combine to form simple visual representations. While the technology does not aim to restore normal sight, the resulting signals could allow users to identify objects, perceive obstacles, and navigate their environment.

Development of the Occular system began in 2020, and the company says it has undergone extensive preclinical testing, including animal studies lasting more than 2 years. ReVision Implant says it has prioritized long-term device performance and durability from the earliest stages of development.

Receiving FDA Breakthrough Device designation provides the company with a faster and more collaborative regulatory pathway. The designation allows ReVision Implant to receive early feedback from regulators on clinical trial protocols, data requirements, and regulatory strategy, while also granting access to the FDA’s Total Product Life-Cycle Advisory Program (TAP) Pilot.

The company plans to conduct an initial short-term clinical test during a scheduled brain surgery in October 2026. If regulatory approvals are obtained, early-stage human clinical trials involving blind volunteers could begin as soon as summer 2027.

Because the implant stimulates the visual cortex directly, ReVision says the technology may be applicable to a broad range of blindness causes, including retinal degeneration and optic nerve damage. ReVision estimates that, if clinical trials are successful, the system could eventually benefit around 650,000 patients in the United States and European Union who currently have no effective treatment options.

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