ReVision Implant’s Occular brain-computer interface (BCI) for treating blindness has obtained breakthrough device designation from the US Food and Drug Administration (FDA), setting a course for the company’s initiation of a first-in-human (FIH) clinical trial of the system.
The Belgian neurotechnology company’s Occular system is being developed to restore vision by interfacing directly with the brain’s visual cortex to bypass damaged regions of the eye or optic nerve.
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Intended to restore functional vision in patients with severe blindness, including those whose condition cannot be treated with retinal implants or optic nerve therapies, Occular captures visual information via a camera mounted on a wireless headset. This data is transmitted to a brain implant that stimulates neurons, the patterns of which are interpreted by the brain as points of light. These signals combine to form simple visual representations to help those fitted with the system to identify objects and navigate their surroundings.
Given that Occular’s implant stimulates the visual cortex directly, ReVision asserts that the technology may be suitable for patients with a wide range of conditions that cause blindness, including retinal degeneration and optic nerve damage.
With the FDA designation in hand, ReVision now anticipates conducting a short-term clinical trial of Occular during a scheduled brain surgery in October 2026, with early-stage human clinical trials in blind volunteers expected to begin in 2027.
ReVision added that the FDA designation means it will be able to obtain early feedback on regulatory roadmaps and clinical trial protocols for Occular. The breakthrough tag also grants the company access to the FDA’s Total Product Life-Cycle Advisory Program (TAP) Pilot. Expanded in October 2023 to cover neurological and physical medicine devices, TAP is intended to help companies accelerate the development of their technologies.
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By GlobalDataReVision’s CEO, Frederik Ceyssens, said: “While cochlear implants have transformed treatment for hearing loss, there is still no widely available neuroprosthetic solution for restoring vision.
“Our aim is to provide people living with severe blindness with functional vision that improves independence and quality of life.”
The BCI scene for treating blindness
According to GlobalData analysis, the global neurology devices market is projected to reach a valuation of over $25bn in 2034.
In healthcare, BCI technologies are on a rapid growth course. Morgan Stanley estimates there to be an early total addressable market (TAM) of $80bn across three million US adults for BCI technology, potentially reaching $320bn with further advancements.
Beyond companies such as Neuralink, which have gained widespread attention for their development of BCIs to give amputees the ability to control their prosthetic limbs through ‘thought alone’, BCIs’ application for visual restoration appears to be on the rise.
On 6 March, Science Corporation closed an oversubscribed $230m Series C financing round that it plans to use towards advancing the commercial activities for its Prima BCI retinal implant for vision restoration.
Science’s Prima BCI beams visual signals directly to the brain using a mix of augmented reality (AR) technologies alongside an ultra-thin microchip implanted under the retina.
In October 2025, Science published results from its PRIMAvera pivotal trial (NCT04676854) in the New England Journal of Medicine. Out of 38 patients with visual impairment due to dry age-related macular degeneration (dry AMD) who were implanted with Prima, the trial demonstrated that 84% of patients were able to read again once fitted with the BCI.
Having submitted a regulatory application in Europe and with the FDA, Science now anticipates its first approval for the system in Europe, with the region’s launch expected later this year.
