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

Rhea-AI Summary

AEYE Health and Topcon Healthcare have announced breakthrough results in autonomous diabetic retinopathy screening, combining Topcon's NW500 non-mydriatic retinal camera with AEYE Diagnostic Screening (AEYE-DS). The solution achieved 92% sensitivity and 90% specificity, with unprecedented 100% imageability and >99% success on first attempts without dilation.

AEYE-DS, already FDA-cleared for use with Topcon's TRC-NW400 and accessible through the Harmony® platform, is seeking additional clearance for the NW500 combination. The system requires only a single image per eye and completes screenings in under one minute without dilation.

This advancement addresses a critical healthcare need, as over 40 million Americans and 830 million people worldwide have diabetes, with 85% of diabetic patients over 40 at risk of developing diabetic retinopathy, the leading cause of blindness in working-age adults.

Positive

• Achieved exceptional clinical efficacy with 92% sensitivity and 90% specificity
• Reached 100% imageability with >99% success rate on first attempts
• Reduced screening time to under one minute per patient
• Already FDA-cleared for use with TRC-NW400 model

Negative

• Additional FDA clearance still required for NW500 combination

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.

Media Contact – AEYE Health
AEYE Health Press Team
press@aeyehealth.com 

Media Contact – Topcon Healthcare
Leslie Amodei
Topcon Healthcare
VP, Marketing for Americas
lamodei@topcon.com 

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SOURCE AEYE Health

FAQ

What are the clinical efficacy rates of AEYE-DS with Topcon's NW500 camera for diabetic retinopathy screening?

The combination achieved 92% sensitivity and 90% specificity in clinical diagnostic efficacy, with 100% imageability and >99% success rate on first attempts without dilation.

How long does a diabetic retinopathy screening take with AEYE-DS and Topcon NW500?

The screening takes under one minute per patient, requiring only a single image per eye without dilation.

Is AEYE-DS FDA-cleared for use with Topcon's cameras?

AEYE-DS is FDA-cleared for use with Topcon's TRC-NW400 model and is currently seeking additional clearance for the NW500 combination.

What percentage of diabetic patients are at risk of developing diabetic retinopathy?

An estimated 85% of patients with diabetes over the age of 40 will develop diabetic retinopathy.

How many images per eye does AEYE-DS require for diabetic retinopathy screening?

AEYE-DS requires only a single image per eye for autonomous screening.