A California-based start-up has secured European regulatory approval for its bionic eye device designed to restore sight in patients with late-stage age-related macular degeneration, marking a significant milestone in the field of brain-computer interfaces.
Science Corp announced that it received the European Union’s Conformité Européenne (CE) mark for its Prima device, a wireless retinal implant paired with specialized glasses. This approval clears the way for the company to begin commercial treatments in Europe, with Germany expected to be the initial market. The company has also obtained humanitarian use designation from the US Food and Drug Administration, an important step toward potential commercial availability in the United States.
Founded in 2021 by Max Hodak, a former co-founder of Neuralink, Science Corp’s Prima system targets a form of macular degeneration that affects hundreds of thousands worldwide. Clinical trials involving 38 patients showed that 84 percent were able to read letters, numbers, and words with the device, without impairment to their remaining natural vision.
The Prima implant is surgically inserted beneath the retina, where it receives near-infrared light signals transmitted wirelessly from augmented reality glasses. These light signals are converted into electrical impulses that stimulate the brain’s visual processing centers.
Hodak described the current version of the device as an early iteration that provides black-and-white vision through a relatively narrow field, likening the experience to “looking through a straw in the centre of their vision.” He expressed optimism about future improvements, including the potential for near-native color vision and higher resolution.
The underlying technology originated from research at Stanford University. Science Corp acquired the French company overseeing Prima’s development in 2024, building on years of clinical and regulatory progress.
Prima’s arrival in the market contrasts with earlier attempts at visual prosthesis devices. Second Sight, an earlier implant maker, obtained CE approval in 2011 for its Argus system but faced financial difficulties by 2020. Though the company was later acquired, Argus is no longer commercially available, positioning Prima as the only currently marketed device of its kind.
The commercialisation of Prima reflects broader advances in brain-computer interface technologies. Recently, Chinese regulators approved a brain implant developed by Shanghai-based Neuralace to help paralyzed patients regain hand movement, marking another significant milestone. Meanwhile, other companies such as Merge Labs, backed by OpenAI CEO Sam Altman, aim to develop more integrated human-AI interfaces.
Since its founding, Science Corp has raised nearly $500 million in funding, including $230 million in a March 2024 financing round that valued the company around $1.5 billion. Hodak indicated that revenues from Prima’s commercial rollout would underpin further research into more advanced “biohybrid” brain-computer interface technologies, which seek to connect living neurons directly to the brain rather than relying on wired systems. He called the device’s market entry “the financial backbone” supporting the company’s broader ambitions.