Oku Digital Health, a La Jolla, Calif., company spun out of Topcon Healthcare, introduced Connected Care on Oct. 6, a service that captures retinal images during routine eye exams and returns AI-supported insights on heart and other systemic disease risk. The company says it reaches more than 10,000 care locations, but its launch materials do not claim FDA clearance for an Oku-branded cardiovascular risk model.
That gap shapes how the product should be read, and it sits beside a broader claim: that the eye can serve as an entry point for catching disease well beyond ophthalmology.
How Connected Care works
According to Oku's announcement, the software captures retinal images at the point of care during primary or comprehensive eye visits. It then delivers AI-supported insights into the eye care practice's electronic health record workflow, and higher-risk patients are routed on to appropriate care. It integrates with Topcon Harmony, which combines imaging with clinical data, and offers AI-enabled triage and decision dashboards.
Oku said the analysis looks for signs associated with cardiovascular disease, chronic kidney disease, hypertension, diabetic retinopathy, glaucoma and age-related macular degeneration. Biological age insights are also part of the offering.
Image ingestion works with equipment from any vendor, the company said, though it is most tightly integrated with Topcon devices. The product supports two-way referral and co-management with specialists. Oku also said it supports HEDIS EED and Medicare Advantage Star measures, the quality benchmarks health plans use to judge things like diabetic eye exam completion.
Ali Tafreshi, Oku's CEO, framed the pitch around both sides of the referral relationship. "Primary care practices face a significant operational burden in closing quality care gaps, while eye care practices are looking for ways to expand their clinical role and strengthen patient relationships," he said.
What the company does not claim
Oku's materials say the AI looks for "signs associated with cardiovascular disease." They stop short of claiming FDA clearance for cardiovascular risk prediction. A provider FAQ says autonomous AI diabetic retinopathy results are available within Oku workflows, yet the company does not present an FDA-cleared, Oku-branded cardiovascular model.
The nearest related asset belongs to Toku. Topcon signed a definitive agreement to acquire that company on Oct. 17, 2025. Toku's CLAiR AI uses retinal images to assess cardiovascular risk, biological age and chronic kidney disease, and the company obtained CE and UKCA marks, the European and British conformity approvals, for AI cardiovascular risk assessment on Feb. 5, 2024. I found no announcement of U.S. FDA clearance for Toku's cardiovascular product as of Oct. 31, 2026.



