United States – October 17, 2026 -- Digital Diagnostics says its LumineticsCore system avoided 91% of unnecessary specialty visits in a pivotal clinical trial and cut time-to-follow-up for positive patients from 60 days to 5 days. The company made the claims in AdvaMed's "The Insight Series: AI & Digital Health," speaking through Jacque Engle, Vice President of Marketing & Communication, and Juli Goldstein, Vice President of Government Affairs & Market Access.
LumineticsCore delivers diabetic retinopathy diagnoses at the point of care without specialist overread
The company describes LumineticsCore as the first fully autonomous AI diagnostic system cleared by the FDA in any medical specialty. It detects diabetic retinopathy, a common diabetes complication and a leading cause of blindness. The FDA cleared the system in 2018, and it was one of the first to receive breakthrough device designation after the 21st Century Cures Act was signed.
A diabetes patient can receive a retinal diagnosis during a primary care or family medicine visit, the company says, with no specialist appointment. Engle said clinicians still order the exam, explain results and set treatment and referral plans. She also said the system was trained and validated to mitigate bias across sex, race and ethnicity.
Access gap drives the commercial case: 60,000 people go blind yearly and as few as 15% get annual exams
Goldstein said more than 60,000 people go blind from diabetic retinopathy each year, though the condition is almost entirely preventable if caught early. As few as 15% of people with diabetes receive the annual eye exam they need. She argued AI can close that gap at scale in a way that adding specialists cannot.
Engle said a finding of diabetic retinal disease also serves as an early warning of stroke, kidney failure and peripheral vascular disease risk.
CPT Code 92229 gives autonomous AI a reimbursement path
Goldstein said sustainable reimbursement is key to scaling adoption. Digital Diagnostics obtained the autonomous AI CPT code in the medical section of the CPT code book (CPT Code 92229), along with related quality measures that can make reimbursement possible. She described this as an industry first.
Engle said approved AI tools often sit on the shelf for years while reimbursement and coverage debates play out. Rural and vulnerable communities go without in the meantime. She called for AI developers, policymakers, payers, health systems, associations and clinicians to build pathways in parallel rather than in sequence.
Company targets macular degeneration and glaucoma through a single eye-imaging platform
Goldstein said ophthalmology led the way and that algorithms are likely to help diagnose age-related macular degeneration and glaucoma. She described a possible single AI-enabled platform that could diagnose all of these conditions through eye imaging, which she said holds promise for non-invasive imaging and lower cost of care. She also pointed to chronic disease management, rural communities and resource-limited settings as future areas for autonomous AI.
Company founder Dr. Michael Abramoff has said patients can be diagnosed by a "street-legal" autonomous AI that is FDA-cleared and reimbursable, even though no street-legal fully autonomous car can be bought.
Goldstein said the company is now building a platform approach rooted in systemic disease detection using non-invasive, lower-cost ocular imaging. She said a routine eye exam could one day serve as an early warning system for serious and costly diseases.