Source: Eye Future; Editor: Sophia
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Recently, AEye Health, a leading company in the field of artificial intelligence retinal imaging and diagnosis, AEYE Health Announced that itsThe World's FirstFor portableDiabetic RetinopathyFully Automatic Artificial Intelligence System for Screening（AEYE-DS）Received FDA Approval。This is also the FDA's approvalThe First Fully Automatic Ophthalmic Screening Artificial Intelligence System. AEYE-DS is alsoThe Only OneA solution that screens patients using just one image per eye.Imaging rate exceeds 99%,Therefore, it can beDiagnostic screening process compressed to 1 minute。The device will be fully autonomous.The combination of artificial intelligence and portable handheld devices, introducing a new, cost-effective screening solution,Helps prevent blindness in the working-age population,The product is easy to operate, suitable for patient self-screening and primary care.。
# Research and Development BackgroundPublic information shows,Diabetic Retinopathy (DR)One of the most common microvascular complications of diabetes, affecting approximately 30% of diabetic patients. The diseaseIt is the leading irreversible blinding disease among working-age adults and the primary cause of blindness in adults.。More than 420 million people with diabetes worldwide are at risk of diabetic retinopathy and need to be screened annually.Early diagnosis and intervention are key to preventing blindness., although more than 90% of vision loss caused by diabetes can be avoided through early detection and treatment,But about 60% of diabetes patients in the U.S. still do not get tested annually。Now imagine this scene:People hold a small device, and with a quick click, the device captures a retinal image. Moments later, a fully autonomous artificial intelligence detects signs of diabetic retinopathy.。The artificial intelligence model developed by AEYE Health not only complements the work of retinal disease experts but also enhances current diagnostic capabilities. It can detect signs of diabetes-related complications in images that retinal disease experts consider healthy, aiding in earlier diagnosis and providing opportunities for appropriate treatment and mitigation of complications.This artificial intelligence system can be paired with a portable handheld camera, from which it obtainsIn retinal imagesDiagnosed with diabetic retinopathy.
November 2022, AEYE Health announced that its AI-based autonomous diagnostic screening system for diabetic retinopathy (DR) received approval in the United States.FDA 510(k) Certification, can be used for those not previously diagnosed with DRAdults aged 22 years and above with mild or more severe DRAutomatic detection.It is reported that this AEYE-DSUsed the innovative desktop retinal camera Topcon NW-400。
AndThis FDA approval is for the portable camera diagnostic screening solution launched by AEYE Health.。Portable solutions are particularly suitable for bedside screening, allowing screening to be performed wherever the patient is, whether in a clinic or at home.
In addition, AEYE-DS is alsoThe Only OneA solution that screens patients using only one image per eye, with an imaging rate exceeding 99%., rarely neededMydriasis。
AEYE-DS will be approved afterwardsLaunched alongside desktop imaging devices, becomingThe First and OnlyAllow useOptomed Aurora Portable Handheld DeviceAI solutions for autonomous screening anywhere.This FDA approval is based on AEYE-DS.Two large-scale prospective Phase 3 clinical studies,AEYE-DS Demonstrates better efficacy and imaging capabilities than similar products。Clinical research results show that the diagnostic sensitivity of the AI system in 92%-93%Between, specificity in89%-94% Between.In these two studies,99% All of the above patientsObtained the diagnostic results of diabetic retinopathy imaging.AEye Health is stillAdvance a GlaucomaOptic NeuropathyScreening ProgramClinical studies have already shown that the product has excellent diagnostic potential, with a sensitivity of 92.2% and specificity of 92.6%. The pivotal FDA trial is expected to commence soon.
Co-founder and CEO of AEYE HealthDr. Zack Dvey-AharonIndicates:"The FDA's first approval of this fully automated artificial intelligence diagnostic system is the 'Holy Grail' in the field of ophthalmic screening."By using AI in combination with portable or desktop retinal cameras,Now it only takes one minute to complete the operation, while delivering best-in-class diagnostic results.In the coming years, our fully automated screening technology will become a standard feature at healthcare facilities across the U.S. We believe this innovation will prevent millions of people in the U.S. and around the world from going blind."
AEYE Health, established in 2018, is a venture capital-backedDigital Healthcare Startups, whose developed artificial intelligence algorithm can provide instant, fully autonomous point-of-care interpretation of fundus images for various diseases.Flagship Product AEYE-DS Enables Point-of-Care Screening for Diabetic Retinopathy, ensuring that diabetes patients can conveniently and regularly undergo screening.In markets outside the United States, AEYE Health has implemented its AEYE-CS (Comprehensive Screening) solution.Provided an AI screening system covering more than 30 indications, covering indications for vision-threatening and systemic diseases.AEYE Health's AI-based high-precision diagnostic screening solution effectively assists primary care providers in on-site patient screening and diagnosis. This solution helps ensure that patients, especially those in underserved and often undiagnosed communities, can easily and quickly receive critical blindness-preventing screenings.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
