Bionic Eye Granted FDA Breakthrough Device Designation

Image credit: Pixium Vision

Bioelectronics company, Pixium Vision has received a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its bionic eye.

It is hoped the innovative device, known as the Prima System, will help to partially restore vision for patients with atrophic dry macular degeneration.

The system replaces failing light receptors in the back of the eye via a tiny wireless retinal implant, which is used in conjunction with a pair of camera-mounted glasses and a small processor.

Pixium Vision’s Chief Executive Officer, Lloyd Diamond said the FDA’s approval of the new breakthrough designation meant working closer with the agency during its forthcoming premarket review.

“This designation not only helps us to expedite the development of the Prima System but also affords us the opportunity of working closely with the FDA in refining the Prima System for its US regulatory submission,” said Diamond in a press statement.

“In addition, after receiving market authorization, there are outpatient and inpatient reimbursement pathways that are more readily accessible as a result of receiving Breakthrough Device Designation.”

The announcement comes around three months after Pixium confirmed its completion of a clinical trial in Europe, implanting the device in 38 patients. Early findings are due later this year, with feasibility studies also underway in the US and France.

Read the full announcement from Pixium Vision.