The FDA has granted Belgian neurotech company ReVision Implant Breakthrough Therapy Designation (BTD) for its brain-computer interface (BCI) implant for treating blindness.
What do we know about this company?
Operating out of Leuven, Belgium, the private medical device startup was founded with the intent to develop a cortical (visual) prosthesis (implant) capable of bypassing damaged eyes and delivering visual information directly to the brain.
- Its target patients: Those with blindness or severe vision loss, including whose condition cannot be treated with retinal implants or optic nerve therapies.
Next: The visual prosthesis.
For some background on—and the components of—a visual prosthesis, see here (hint: it involves a camera, implant, and electronics & algorithms).
See also the key issues ReVision has identified with these devices.
And ReVision’s variation of this?
That would be the Occular system, designed to directly stimulate the brain’s visual cortex.
This prosthesis is based on ReVision’s advanced and flexible micro-electrode technology, which powers the implantation of those aforementioned “electrodes in the brain, each as thin as a single cell” as well as:
- Minimizes scar tissue formation
- Enables scaling up to a high resolution
As for its composition: The system blends together thousands of electrode arrays directly in the visual cortex and utilizes advanced stimulation patterns to achieve higher resolution (equivalent to a greyscale image of over 1,000 pixels).
Take a closer look at these electrodes.
Composed of soft, highly biocompatible materials, the ultra-flexible electrode arrays are built using semiconductor fabrication technology and advanced materials that enable “sufficient charge injection despite the small electrode size.”
- They also cover “a large fraction of the visual cortex,” allowing for “resaturation of both peripheral and central vision” field of view.
Go on …
A major win (particularly by FDA standards): ReVision reports that its electrode arrays have demonstrated long-term stability under continuous stimulation conditions, meeting the minimum of a 10-year lifetime standard.
- Why this matters: The FDA generally expects manufacturers to demonstrate that an implant and its critical components (such as electrode arrays) are reliable and safe for about a decade or longer under physiological conditions.
And its insertion method?
This is based on the company’s patented technique that leaves behind minimal tissue damage (as evidenced in an animal model evaluation).
- See here for the details.
So with all of this in mind—how does Occular work?
- First, a miniature camera mounted on a wireless headset captures visual information
- This data is then transmitted to a brain implant and converted into electrical stimulation patterns
- Then, microelectrode implants within the visual vortex stimulate specific neurons
- From there, the brain interprets those signals as visual perception
And the end-game goal?
Importantly: It isn’t necessarily for a patient to have perfect natural sight—rather, for them to achieve functional vision.
- Examples of this include recognizing shapes, detecting objects, or navigating spaces.
Duly noted. Now, at long last: Explain this FDA designation.
Not to be confused with Breakthrough Therapy Designation, Breakthrough Device Designation (BDD) is intended to expedite the development, assessment, and review process of certain medical devices for premarket approval, 510(k) clearance, or De Novo marketing authorization.
Once granted BDD: A company can receive FDA feedback on their device development via several options, as well as a prioritized review for future regulatory submissions of the device.
And in the case of the Occular system?
The designation allows for ReVision to receive early feedback on its planned regulatory pathway (data and clinical trial protocols) for the technology—as well as gives them access to the FDA’s Total Product Life-Cycle Advisory Program (TAP) Pilot.
What this is: Launched in 2022 by the federal agency’s Center for Devices and Radiological Health (CDRH), the voluntary program is intended to accelerate patient access to high-quality, safe, and effective medical devices by:
- Providing early, frequent, and strategic communications with the FDA
- Facilitating engagement with breakthrough device manufacturers to:
- De-risk development
- Enhance evidence generation
- Improve submission quality
Got it. What’s the plan moving forward?
A first short-term clinical trial during a scheduled brain surgery is expected to be initiated later this fall (October 2026).
Beyond that: ReVision is reportedly planning to kick off early-stage human clinical trials in blind volunteers in mid-2027 (pending regulatory approvals).