US-based digital health company AEYE Health has received the US Food and Drug Administration (FDA) approval for its AEYE Diagnostic Screening technology (AEYE-DS).

AEYE-DS is a fully autonomous AI tool that enables the diagnosis of referable diabetic retinopathy using retinal images obtained by a handheld camera.

It combines a fully autonomous AI with a portable handheld device, offering a new and affordable screening solution to address the primary cause of blindness in the working age.

Also, the portable solution is suited for point-of-care screening, enabling screenings wherever patients are located, either in a clinic or at home, said the digital health company.

The AEYE-DS technology is already approved in the US and is commercially available with a tabletop imaging device.

With the FDA approval, it will be the first and only AI solution to enable autonomous screening anywhere, using the Optomed Aurora portable handheld device.

In addition, AEYE-DS is the only AI solution that screens patients using just one image per eye with more than 99% imageability, said AEYE Health.

AEYE Health co-founder and CEO Zack Dvey-Aharon said: “This is the ‘holy grail’ of eye screening – fully autonomous AI, using either portable or tabletop retinal cameras and a procedure that takes a minute to perform, alongside the best-in-class diagnostic efficacy.

“In the coming years, our fully autonomous screening technology will become standard across points of care in the US. We believe this innovation will prevent the blindness of millions of people in the US and around the world.

“AEYE keeps working to expand the boundaries of diagnostic screening beyond diabetic retinopathy. Our science is evidently the strongest in this space and we’re proud to make such an unbelievable impact.”

The FDA approval is based on two large-scale Phase 3 clinical trials, in which AEYE-DS showed superior efficacy and imageability.

In the studies, the AI solution showed diagnostic sensitivity in 92%-93% and specificity in 89%-94%, providing diagnostic results to over 99% of patients.

The AI tool produced its diagnostic results using a single image from each eye, which rarely required a dilation.

Screening for diabetic retinopathy using AI is important for public health and is now reimbursable in the US, through a new AI CPT code 92229 for autonomous screening.

In October last year, AEYE Health partnered with Topcon Screen to offer diabetic retinopathy screening using its AEYE-DS technology and Topcon’s fully automated and robotic retinal camera, TRC-NW400.

The partnership was designed to provide AI-based diabetic retinopathy screening at point-of-care to generate immediate and accurate results.