AEYE Health in partnership with Topcon Healthcare, Inc, Announces Exceptional Usability and Clinical Efficacy for Autonomous Diabetic Retinopathy Screening
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.
AEYE Health e Topcon Healthcare hanno annunciato risultati rivoluzionari nello screening autonomo della retinopatia diabetica, combinando la fotocamera retinica non midriatica NW500 di Topcon con lo Screening Diagnostico AEYE (AEYE-DS). La soluzione ha raggiunto una sensibilità del 92% e una specificità del 90%, con un'impareggiabile capacità di imaging del 100% e oltre il 99% di successo ai primi tentativi senza dilatazione.
AEYE-DS, già approvato dalla FDA per l'uso con il TRC-NW400 di Topcon e accessibile tramite la piattaforma Harmony®, sta cercando un'ulteriore approvazione per la combinazione NW500. Il sistema richiede solo un'immagine per occhio e completa gli screening in meno di un minuto senza dilatazione.
Questo progresso risponde a un bisogno critico nella sanità, poiché oltre 40 milioni di americani e 830 milioni di persone nel mondo hanno il diabete, con l'85% dei pazienti diabetici over 40 a rischio di sviluppare retinopatia diabetica, la principale causa di cecità negli adulti in età lavorativa.
AEYE Health y Topcon Healthcare han anunciado resultados innovadores en el cribado autónomo de retinopatía diabética, combinando la cámara retinal no midriática NW500 de Topcon con el Screening Diagnóstico AEYE (AEYE-DS). La solución logró una sensibilidad del 92% y una especificidad del 90%, con una capacidad de imagen sin precedentes del 100% y más del 99% de éxito en los primeros intentos sin dilatación.
AEYE-DS, ya aprobado por la FDA para su uso con el TRC-NW400 de Topcon y accesible a través de la plataforma Harmony®, busca una aprobación adicional para la combinación NW500. El sistema requiere solo una imagen por ojo y completa los cribados en menos de un minuto sin dilatación.
Este avance aborda una necesidad crítica en la atención médica, ya que más de 40 millones de estadounidenses y 830 millones de personas en todo el mundo tienen diabetes, con el 85% de los pacientes diabéticos mayores de 40 años en riesgo de desarrollar retinopatía diabética, la principal causa de ceguera en adultos en edad laboral.
AEYE Health와 Topcon Healthcare는 Topcon의 비산동 망막 카메라 NW500과 AEYE 진단 스크리닝(AEYE-DS)을 결합한 자율 당뇨병성 망막병 검사에서 혁신적인 결과를 발표했습니다. 이 솔루션은 92%의 민감도와 90%의 특이도를 달성했으며, 전례 없는 100%의 이미지 가능성과 99% 이상의 성공률을 보였습니다. 이 모든 것은 확장 없이 첫 시도에서 이루어졌습니다.
AEYE-DS는 이미 Topcon의 TRC-NW400과 함께 FDA 승인을 받았으며, Harmony® 플랫폼을 통해 접근할 수 있습니다. NW500 조합에 대한 추가 승인을 요청하고 있습니다. 이 시스템은 각 눈당 단 하나의 이미지만 필요하며, 확장 없이 1분 이내에 검사를 완료합니다.
이 발전은 4천만 이상의 미국인과 8억 3천만 명의 전 세계 사람들이 당뇨병을 앓고 있는 중대한 건강 문제를 해결합니다. 당뇨병 환자 중 85%가 40세 이상으로, 이는 근로 연령 성인의 실명 주요 원인인 당뇨병성 망막병증이 발생할 위험이 있습니다.
AEYE Health et Topcon Healthcare ont annoncé des résultats révolutionnaires dans le dépistage autonome de la rétinopathie diabétique, en combinant la caméra rétinienne non mydriatique NW500 de Topcon avec le dépistage diagnostique AEYE (AEYE-DS). La solution a atteint une sensibilité de 92 % et une spécificité de 90 %, avec une capacité d'image sans précédent de 100 % et plus de 99 % de succès lors des premiers essais sans dilatation.
AEYE-DS, déjà approuvé par la FDA pour une utilisation avec le TRC-NW400 de Topcon et accessible via la plateforme Harmony®, cherche une approbation supplémentaire pour la combinaison NW500. Le système nécessite seulement une image par œil et complète les dépistages en moins d'une minute sans dilatation.
Cette avancée répond à un besoin critique en matière de santé, car plus de 40 millions d'Américains et 830 millions de personnes dans le monde souffrent de diabète, avec 85 % des patients diabétiques de plus de 40 ans à risque de développer une rétinopathie diabétique, la principale cause de cécité chez les adultes en âge de travailler.
AEYE Health und Topcon Healthcare haben bahnbrechende Ergebnisse im autonomen Screening von diabetischer Retinopathie bekannt gegeben, indem sie die nicht-mydriatische Netzhautkamera NW500 von Topcon mit dem AEYE Diagnostischen Screening (AEYE-DS) kombiniert haben. Die Lösung erzielte eine Empfindlichkeit von 92% und eine Spezifität von 90%, mit einer beispiellosen Bildbarkeit von 100% und über 99% Erfolg bei den ersten Versuchen ohne Dilatation.
AEYE-DS, das bereits von der FDA für die Verwendung mit dem TRC-NW400 von Topcon zugelassen ist und über die Harmony®-Plattform zugänglich ist, strebt eine zusätzliche Genehmigung für die Kombination mit NW500 an. Das System benötigt nur ein einziges Bild pro Auge und schließt die Screenings in weniger als einer Minute ohne Dilatation ab.
Dieser Fortschritt adressiert einen kritischen Gesundheitsbedarf, da über 40 Millionen Amerikaner und 830 Millionen Menschen weltweit an Diabetes leiden, wobei 85% der diabetischen Patienten über 40 Jahre alt sind und ein Risiko haben, eine diabetische Retinopathie zu entwickeln, die die Hauptursache für Erblindung bei erwerbsfähigen Erwachsenen ist.
- 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
- Additional FDA clearance still required for NW500 combination
Powerful combination delivers immediate, dilation-free, fully autonomous AI diagnostic screening with
In a recent study, AEYE-DS AI technology, in conjunction with the Topcon NW500, demonstrated unparalleled results, including:
- Exceptional clinical diagnostic efficacy:
92% sensitivity and90% 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
"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
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
lamodei@topcon.com
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SOURCE AEYE Health
FAQ
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