Science Corp. launches PRIMA retinal implant in Europe after CE mark
The wireless retinal chip, approved for vision loss from geographic atrophy, can now be sold across 30 European countries; US approval is still pending.
Science Corporation has launched PRIMA, its retinal implant for people who have lost central vision, in Europe after receiving a CE mark under the EU Medical Device Regulation. The certification allows sales in 30 European countries, and the company expects the first commercial implantation in Germany.
What PRIMA does
PRIMA is a tiny wireless chip placed under the retina. Special glasses project infrared light onto it, and the chip turns that light into electrical stimulation of the remaining retinal cells. It is approved for geographic atrophy, an advanced form of age-related macular degeneration that destroys the light-sensing cells in the center of vision.
The evidence
In the clinical trial supporting approval, participants improved by an average of 25.5 letters on a standard eye chart. 84% could read letters, numbers and words with the implant. The company says PRIMA is the first device of its kind certified for restoring this kind of “form” vision.
US status
PRIMA has FDA Breakthrough Device and Humanitarian Use Device designations, but it is not yet approved in the US. Science says it is working with the FDA toward approval.
Why it matters
Vision restoration has had several false starts. A CE-marked device with readable-text results is a milestone for visual prostheses and for Science, the company co-founded by Neuralink co-founder Max Hodak.
Learn more: Visual prosthesis · Breakthrough Device designation · Science Corp. in the Directory