STORY RECORD
Bionic eye implant approved in Europe
Science Corporation's PRIMA retinal implant received CE mark approval for commercial sale in Europe to treat geographic atrophy from dry age-related macular degeneration, a leading cause of blindness.
CEO Max Hodak announced the milestone, with Science Corp's official account saying the first European commercial implant is expected soon.
The device is a sub-retinal chip paired with camera-equipped AR glasses that project infrared visual data onto functional neurons, and has been described as 'Cochlear implant for blindness' by STAT News.
Separately, Hodak revealed the FDA has granted Humanitarian Use Device designation, potentially enabling US availability by early to mid 2027. Hodak said rollout will start slowly by country, prioritizing surgeon training before scale-up.
This makes Science Corp's PRIMA the first device from a US brain-computer interface company to reach paying patients rather than clinical trial participants.
Why It Matters
This is the first commercial retinal implant from a US neurotech company — a concrete regulatory win that shifts the brain-computer interface narrative from lab hype to real patient access.
PRIMA targets dry age-related macular degeneration, one of the most common causes of blindness with no widely available restorative treatment.
Success in Europe could open a commercial pathway for Science Corp's longer-term brain implant ambitions and validate the broader BCI sector for investors and regulators.
The Facts
8Science Corporation's PRIMA visual prosthesis has received CE mark approval for marketing in Europe, making it commercially available for patients with geographic atrophy from dry age-related macular degeneration.
strongly supported · confidence 0.85
The PRIMA implant is a sub-retinal chip paired with camera-equipped AR glasses that project visual data via infrared light to stimulate functional neurons, enabling patients to regain some central vision.
supported · confidence 0.75
Science Corp's official account stated the first European commercial implant of PRIMA is expected soon, and described it as the first and only treatment to be commercially available that restores functional central vision for geographic atrophy.
supported · confidence 0.8
Science Corporation submitted the CE mark application for PRIMA in June 2025, as confirmed by the company's website.
supported · confidence 0.8
The FDA has granted PRIMA Humanitarian Use Device designation, which enables use of the Humanitarian Device Exemption approval pathway for potential US availability possibly in early to mid 2027 for very late stage vision loss patients.
supported · confidence 0.75
Hodak stated the European rollout will happen country by country, starting slowly to allow surgeons to get practiced with the procedure before pushing for scale.
supported · confidence 0.8
Bloomberg and the Financial Times both independently reported the CE mark approval and described it as a milestone for Science Corp's longer-term goal of bringing brain implants to market.
supported · confidence 0.8
STAT News described PRIMA as a 'Cochlear implant for blindness' in their coverage of the European launch.
supported · confidence 0.7
Still Open
1- ContradictionContradiction note is limited to snapshotted evidence.contradicted