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AEYE Health

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AEYE Health is an American technology company specializing in artificial intelligence-based diagnostics for retinal imaging.[1][2] Founded by Zack Dvey-Aharon and Danny Margalit, the company has offices in New York and Tel Aviv.[3][4]AEYE Health’s FDA-cleared AI technology is utilized at the point of care in environments such as primary care offices, endocrinology clinics, and home care to conduct diabetic eye exams.[5]

History

AEYE Health was founded in 2018 by Zack Dvey-Aharon and Danny Margalit.[2][6] Since its founding, it has received funding from multiple organizations.[7]

In February 2022, AEYE Health reported results from its FDA phase III clinical trial for the autonomous detection of more-than-mild diabetic retinopathy using the AEYE Diagnostic System (AEYE-DS).[5][8][9] Utilizing a single image per eye, the AI system demonstrated 93.0 percent sensitivity and 91.4 percent specificity for detecting referable diabetic retinopathy with over 99 percent imageability on the Topcon NW-400 desktop camera. When tested with the Optomed Aurora handheld camera, it showed 91.9 percent sensitivity and 93.6 percent specificity with over 99 percent imageability.[8] In November 2022, AEYE Health received FDA clearance to market its fully autonomous diabetic retinopathy screening system with a retinal camera.[9][10]

In April 2024, AEYE Health was granted a second FDA clearance for the first fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images obtained by a handheld camera.[11][12] The handheld camera is portable, which enables point-of-care screening both in clinics and at home.[12]

Technology

AEYE Health uses artificial intelligence to autonomously detect various conditions from retinal images and is compatible with several types of retinal cameras, including handheld models.[citation needed] Autonomous AI as defined by the American Medical Association is AI that automatically interprets data and independently generates clinically meaningful conclusions without concurrent physician or other qualified healthcare professional (QHP) involvement.[13]

The proprietary algorithm of the AEYE-DS system analyzes the image and delivers a fully autonomous AI-based diagnosis in seconds.[2]

References

  1. ^ Norman, Hannah (March 22, 2024). "AI is upending eye exams for patients and providers—in a good way: 'It's been a godsend for us'". Fortune.
  2. ^ a b c Orbach, Meir (July 26, 2022). "מונעת עיוורון: Aeye Health פיתחה תוכנת AI לאבחון סוכרת דרך הרשתית | כלכליסט". Calcalist.
  3. ^ Bressler, Idan; Aviv, Rachelle; Margalit, Danny; Rom, Yovel; Ianchulev, Tsontcho; Dvey-Aharon, Zack (2024-05-01). "Autonomous screening for laser photocoagulation in fundus images using deep learning". British Journal of Ophthalmology. 108 (5): 742–746. doi:10.1136/bjo-2023-323376. ISSN 0007-1161. PMID 37217293.
  4. ^ Miller, Sara (2024-07-25). "AI Makes Vital Diabetic Eye Test As Simple As Saying 'Cheese'". NoCamels. Retrieved 2024-11-18.
  5. ^ a b "Zack Dvey-Aharon, co-founder and CEO of AEYE Health named to TIME100 AI list". Modern Retina. 2024-09-27. Retrieved 2024-11-18.
  6. ^ Leichman, Abigail Klein (2023-10-09). "11 promising new technologies to help us see better". ISRAEL21c. Retrieved 2024-11-18.
  7. ^ "BioLight invests in $1m in AEYE Health". March 21, 2021 – via Globes.
  8. ^ a b "AEYE Health reports results of its AI algorithm for autonomous screening and detection of diabetic retinopathy". Ophthalmology Times. February 7, 2022.
  9. ^ a b https://www.reuters.com/business/healthcare-pharmaceuticals/aeye-health-gets-fda-approval-screen-diabetics-prevent-blindness-2022-11-15/
  10. ^ "AEYE Health gains FDA clearance to screen diabetics to head off blindness". Ophthalmology Times. November 15, 2022.
  11. ^ "Optomed Oyj, AEYE Health say portable device to detect eye issues gets FDA nod | Reuters".
  12. ^ a b "AEYE Health receives FDA clearance for first ever fully autonomous AI for portable DR screening". Optometry Times. May 2, 2024.
  13. ^ "CPT Appendix S: AI taxonomy for medical services & procedures". American Medical Association. June 10, 2024.
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