PRIMA Vision-Restoring Brain-Computer Interface Wins EU Approval
Science Corp’s PRIMA vision-restoring brain-computer interface wins EU approval, advancing commercial treatment for macular degeneration.
PRIMA Vision-Restoring Brain-Computer Interface Wins EU Approval
Science Corporation has secured approval from Europe’s medical device regulator to commercially sell its PRIMA vision-restoring brain-computer interface. This milestone allows the startup to begin offering the implant to patients suffering from age-related macular degeneration (AMD), with the first commercial procedures potentially occurring in Germany this September. This regulatory green light represents a tangible transition for the neurotechnology sector. Rather than remaining confined to experimental clinical trials, the technology is now entering the commercial healthcare market, backed by a clear pathway to patient reimbursement. Simultaneously, the US Food and Drug Administration has granted the device a specific designation that serves as the initial step toward an expedited regulatory review. This pathway could eventually allow the device to treat two additional rare forms of blindness, expanding its potential patient population beyond macular degeneration. What Happened The PR…
