Science Corporation has received approval from Europe's medical device regulator to begin selling PRIMA, a small chip implanted in the eye that is designed to restore vision lost to age-related macular degeneration (TechCrunch; Science Corporation). The approval covers the ability to see shapes and read letters, numbers, and words, a first for a brain-computer interface device (Science Corporation). A brain-computer interface is a device that connects directly to the body's nervous system to help restore a function that has been lost.

PRIMA works by pairing a tiny chip with a pair of camera-equipped glasses. The chip is placed at the back of the eye during an hour-long procedure that does not require an overnight hospital stay. The glasses capture visual information from the world around the patient, and the chip converts that information into signals the retina can process. Clinical trials were conducted in Germany (TechCrunch).

In those trials, PRIMA was the only treatment to successfully restore the ability to see shapes and read to patients blinded by late-stage macular degeneration (Science Corporation). An independent safety board that reviewed the trial data voted in November 2024 to recommend the device for European regulatory submission (Science Corporation).

The first commercial PRIMA procedure in Europe could take place as early as September 2026. Each device is expected to cost in the hundreds of thousands of dollars (TechCrunch).

Science Corporation founder and CEO Max Hodak co-founded Neuralink and left that company in 2021 to start the firm. Science Corporation acquired Pixium, the French company that originally developed the PRIMA technology, in 2024 (TechCrunch).

On the US side, PRIMA has received a designation from the FDA that constitutes the first step toward a faster regulatory review for two rare forms of blindness (TechCrunch). The specific designation was not detailed in the available reporting, but the pathway positions PRIMA for a potential US market entry should clinical and regulatory milestones be met.

Beyond PRIMA, Science Corporation is working with Dr. Murat Günel, chair of Yale Medical School's Department of Neurosurgery, to develop surgical procedures for human trials of a directly implanted bio-hybrid brain sensor (TechCrunch). That program is earlier-stage and separate from the retinal implant, but it signals the company's broader interest in implanted devices that go beyond restoring vision.

The European approval matters for what it concretely enables: commercial sale across EU member states under a shared regulatory framework, with insurance reimbursement pathways that typically follow. A device priced in the hundreds of thousands of dollars per unit will face scrutiny on cost-effectiveness, but the addressable population is significant. Late-stage macular degeneration progresses to a condition called geographic atrophy, in which cells in the center of the retina deteriorate, and current treatment options are limited. PRIMA's trial data showed vision restoration in precisely that group.

The competitive positioning here is worth noting. Neuralink, the company Hodak co-founded before departing, has pursued a different approach, placing implants directly on the brain for broader neurological applications. Science Corporation, by acquiring Pixium's retinal technology and pursuing a separate sensor pipeline, is taking a different path: starting with the retina, where the relationship between what comes in and what the brain perceives is comparatively well understood, rather than beginning with brain implants where interpreting signals remains substantially harder. The European approval gives PRIMA a commercial position that Neuralink does not yet have in any market.

The historical parallel is instructive. An earlier retinal device called Argus II, approved by the FDA in 2013 for a different eye condition called retinitis pigmentosa, used implanted electrodes to produce small flashes of perceived light. But it struggled with the resolution needed to see shapes and read. PRIMA's trial results claiming restored letter and word recognition suggest a different level of performance. Whether that holds in a broader commercial population, with variable surgeon experience and patient anatomy, is the question the September rollout will begin to answer.

The pricing also bears watching. At hundreds of thousands of dollars per device, PRIMA sits in the range of other advanced implanted medical devices. European health systems will need to see lasting functional outcomes and quality-of-life gains to justify reimbursement at that price. The trial data is encouraging; real-world evidence after launch will be the arbiter.

For now, a neurotechnology company founded five years ago has an approved product addressing a condition with profound unmet need. The September commercial launch will be the first concrete test of whether PRIMA can move from a controlled trial setting into everyday clinical practice.