Science Corp. announced this week that its PRIMA retinal implant has received CE certification from the European Union, clearing the device for sale in 30 European countries. The approval makes PRIMA the first brain-computer interface medical device globally to obtain CE certification.
According to clinical trial data published in The New England Journal of Medicine, 84% of 38 patients implanted with PRIMA successfully restored functional central vision, enabling them to recognize letters, numbers, and words. After 12 months of treatment, 80% of patients showed significant improvement in prosthetic vision without affecting their remaining natural vision. The subretinal photovoltaic implant works with specialized smart glasses that project near-infrared light onto the chip, converting it into electrical signals to stimulate retinal cells. The company expects to implant the first commercial patient by August, with plans for dozens of procedures this year and approximately 200 next year.