AEYE Health, an Israeli digital health company, recently announced US Food and Drug Administration (FDA) clearance for the AEYE Aurora, a handheld device from Optomed that can diagnose referable diabetic retinopathy (DR) from retinal images. The device uses AEYE Diagnostic Screening (AEYE-DS) technology, a fully autonomous artificial intelligence (AI) system, which had previously received FDA clearance for use with a tabletop imaging device. The AEYE Aurora will enable primary care providers to screen and diagnose patients for DR wherever they are, either in the patient’s home or in clinic.

“The launch of Aurora AEYE signifies a major leap in combating diabetic retinopathy,” said Zack Dvey-Aharon, PhD, the CEO of AEYE Health. “By introducing FDA-grade AI in a portable camera, we’re democratizing early detection, making it more accessible and affordable for millions worldwide, eliminating the barriers to traditional health care.”

Aurora AEYE is the first FDA-cleared solution of its kind, requires just one image per eye, and provides instant results directly on the camera screen for patients, along with diagnostic reports for health-care providers. Its portable internet-connected design allows screenings in clinics, patients bedsides and homes. Reimbursement is facilitated by a dedicated CPT code, 92229, for autonomous screening. The device will be unveiled at the American Diabetes Association’s 84th Scientific Session, June 21-24 in Orlando, Fla.