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AEYE Health and Topcon Healthcare Announce Results of Autonomous DR Screening Study

02/11/2025
AEYE Health Partners with Topcon Healthcare Announce Results of Autonomous DR Screening Study image

AEYE Health and Topcon Healthcare announced results of a recent study evaluating Topcon’s NW500 non-mydriatic retinal camera and AEYE Diagnostic Screening (AEYE-DS). 

In the study, the AEYE-DS AI technology, in conjunction with the Topcon NW500, achieved: 

  • Clinical diagnostic efficacy: 92% sensitivity and 90% specificity

  • Imageability: 100% of patients received diagnostic results, with over 99% successfully imaged on the first attempt without dilation

AEYE-DS is FDA-cleared for use with Topcon’s TRC-NW400 and is accessible through the Harmony digital health platform. AEYE Health is now seeking additional clearance for its autonomous screening solution in combination with the Topcon NW500. AEYE-DS remains the only approved autonomous AI solution requiring a single image per eye and, when used with the NW500, eliminates the need for dilation, significantly reducing screening time to under 1 minute, the companies announced in a news release.

Transforming Diabetic Retinopathy Screening with AI

The usability and efficacy demonstrated in clinical studies highlight the potential of the Topcon NW500 with AEYE-DS AI technology to improve diabetic retinopathy screening. The integration with the Harmony platform makes this solution ideal for diverse clinical settings, enabling efficient, on-the-spot diagnostic screening and streamlined referrals for timely treatment.

“This is a great day for blindness prevention, as our partnership with Topcon Healthcare continues to advance diabetic retinopathy screening using AI," Zack Dvey-Aharon, PhS, CEO of AEYE Health, said in the news release. "With Topcon’s NW500, we achieved 100% imageability and virtually 100% success on the first attempt without dilation. This ensures that all patients can be screened immediately, preventing anyone from missing this critical diagnostic opportunity. This remarkable achievement will significantly drive AI screening adoption in the US and globally.”

"To successfully scale diabetic retinopathy screening for all patients, high-quality robotic imaging combined with a robust AI algorithm is essential," said Ali Tafreshi, CEO & President of Topcon Healthcare. "The NW500 with AEYE-DS will empower primary care providers to enhance patient outcomes and increase adherence to diabetic retinopathy screenings. This marks another major milestone in delivering healthcare from the eye.”

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