PRIMA retinal implant receives EU MDR CE mark and goes commercially available across 30 European countries
On 22 July 2026 Science Corporation announced the European commercial launch of PRIMA, stating it is the first and only treatment shown in clinical trials to restore functional central vision to patients with geographic atrophy caused by age-related macular degeneration. PRIMA received a CE mark under the EU Medical Device Regulation from notified body DEKRA, authorising commercial availability across 30 European countries, and the company states it is the first brain-computer-interface device to receive CE marking for form vision restoration - reading letters, numbers and words. Country-specific reimbursement applications and clinical site activations are described as underway, with the first commercial implant expected in Germany. The company cites its New England Journal of Medicine publication covering 38 patients across 17 clinical sites in five countries: mean improvement of 25.5 letters on the ETDRS chart, 84% of patients reporting the ability to read letters, numbers and words, and 80% achieving prosthetic visual acuity improvement of at least logMAR 0.2 at 12 months (p<0.001). The implant is a 2x2mm subretinal photovoltaic device paired with near-infrared projecting glasses. AMD-associated geographic atrophy is stated to affect more than five million people globally.