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Companies results of the combination of Topcon's retinal camera and AEYE Diagnostic Screening

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Key Takeaways

  • The combination of Topcon's NW500 and AEYE-DS achieved 100% imageability and high diagnostic accuracy, with 92% sensitivity and 90% specificity.
  • Over 99% of participants were successfully imaged on the first attempt without dilation, enhancing accessibility and efficiency in screenings.
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A recent study of AEYE-DS AI technology used in conjunction with the Topcon NW500 resulted in exceptional clinical diagnostic efficacy.

Image credit: AdobeStock/ra2 studio

(Image credit: AdobeStock/ra2 studio)

AEYE Health and Topcon Healthcare, Inc., are sharing results of the combination of Topcon's NW500 non-mydriatic retinal camera and AEYE Diagnostic Screening (AEYE-DS). Together, these technologies demonstrated exceptional efficacy and unprecedented 100% imageability, which may set a new standard for accessible, on-the-spot patient care.1

The companies noted in their shared press release1 that a recent study of AEYE-DS AI technology used in conjunction with the Topcon NW500 resulted in exceptional clinical diagnostic efficacy of 92% sensitivity and 90% specificity. The study also saw unprecedented imageability with 100% of patients receiving diagnostic results, and greater than 99% of participants successfully imaged on the first attempt without dilation.

Zack Dvey-Aharon, PhD, CEO of AEYE Health shared his thoughts on this milestone, saying, “With Topcon's NW500, we were able to achieve 100% imageability and virtually 100% success rate on the first attempt without dilation. This means all patients can be screened on the spot, ensuring no one is left out of this critical diagnostic opportunity. This amazing advancement will significantly increase adoption of AI screening in the US and around the world."1

Similarly, Ali Tafreshi, CEO & President of Topcon Healthcare, Inc. is also quoted in the release1 regarding the future steps, saying, "To successfully scale DR screening for all patients, robotic and high-quality imaging combined with a robust AI algorithm is essential. The NW500 with AEYE-DS will empower primary care providers to improve patient outcomes and enhance adherence to diabetic retinopathy screenings. It is another significant milestone in delivering Healthcare from the Eye."

Approvals and future steps

AEYE-DS is already FDA-cleared for use with Topcon's TRC-NW400 and can be accessed through the Harmony digital health platform. AEYE Health is seeking additional clearance for its autonomous screening solution in combination with the Topcon NW500. AEYE-DS is the only approved autonomous AI solution that requires a single image per eye and, with the NW500, does not require dilation therefore significantly improving the time to screen patients to under one minute.2

Reference:
1. AEYE Health in partnership with Topcon Healthcare, Inc, Announces Exceptional Usability and Clinical Efficacy for Autonomous Diabetic Retinopathy Screening. AEYE Health. February 12, 2025. Accessed February 13, 2025. https://www.prnewswire.com/news-releases/aeye-health-in-partnership-with-topcon-healthcare-inc-announces-exceptional-usability-and-clinical-efficacy-for-autonomous-diabetic-retinopathy-screening-302374944.html
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