AEYE Health in partnership with Topcon Healthcare, Inc, Announces Exceptional Usability and Clinical Efficacy for Autonomous Diabetic Retinopathy Screening

Associated Press

12-02-2025

Powerful combination delivers immediate, dilation-free, fully autonomous AI diagnostic screening with 100% imageability for referable diabetic retinopathy
OAKLAND, N.J., Feb. 12, 2025 /PRNewswire/ -- AEYE Health, the premier provider of artificial intelligence-based diagnostics for retinal imaging along with Topcon Healthcare, Inc., a leading provider of digital solutions for 'Healthcare from the Eye™ and robotic diagnostic devices, are pleased to announce groundbreaking results demonstrating exceptional efficacy and unprecedented 100% imageability with the combination of Topcon's NW500 non-mydriatic retinal camera and AEYE Diagnostic Screening ( AEYE-DS). Together, this solution sets a new standard for accessible, on-the-spot patient care.
In a recent study, AEYE-DS AI technology, in conjunction with the Topcon NW500, demonstrated unparalleled results, including:
Exceptional clinical diagnostic efficacy: 92% sensitivity and 90% specificity
Unprecedented imageability: 100% of patients received diagnostic results, with >99% successfully imaged on the first attempt without dilation
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.
This clinical data highlights the exceptional efficacy and unprecedented usability of the Topcon NW500 with AEYE-DS AI technology. The powerful synergy of this solution, including Harmony, makes it ideal for a wide range of clinical settings, enabling on-the-spot, efficient, and accurate diagnostic screening and streamlining 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,' said Zack Dvey-Aharon, Ph.D., CEO of AEYE Health. '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.'
'To successfully scale DR screening for all patients, robotic and high-quality imaging combined with a robust AI algorithm is essential,' said Ali Tafreshi, CEO & President of Topcon Healthcare, Inc. '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.'
Background
Over 40 million people in the U.S. and 830 million worldwide live with diabetes, putting them at risk of diabetic retinopathy, the leading cause of blindness among working-age adults. Alarmingly, an estimated 85% of patients with diabetes over the age of 40 will develop diabetic retinopathy. Early detection through regular screenings is critical, yet many patients face barriers to obtaining annual eye exams. Accessible AI-powered diabetic eye exams at point-of-care offer a practical alternative, significantly increasing adherence to essential screenings.
About AEYE Health
AEYE Health is a digital health company that provides fully autonomous, AI-based diagnostic screening solutions for retinal imaging with best-in-class clinical results and superior usability. The company aims to make diagnostic screening practical, accurate, and accessible. AEYE Health enables point-of-care screening for diabetic retinopathy to ensure that diabetics are regularly screened for diabetic retinopathy. AEYE-DS is the only FDA-cleared autonomous AI for diabetic retinopathy that requires just one image per eye and is the only approved AI for a portable camera.
About Topcon Healthcare, Inc.
Topcon Healthcare, Inc. is part of Topcon Corporation (TSE 7732). We are a leading provider of digital healthcare solutions whose vision is to improve access and quality of healthcare while decreasing the cost of care. To achieve this vision, we created Healthcare from the Eye ™, a connected care ecosystem using AI-powered disease detection and management applied to noninvasive retinal imaging. Healthcare from the Eye is powered by Harmony®, a cloud-based, vendor-inclusive digital health information platform enabling a connected care ecosystem.
A truly global business, Topcon Corporation is focused on developing solutions to solve societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, physician shortages, and unequal access to healthcare. By investing in value-driven innovations, Topcon Corporation works to help people enjoy good health and a better quality of life. For more info, visit Topconhealthcare.com.
Leslie Amodei
Topcon Healthcare