AEYE Health: Difference between revisions

AEYE Health was founded in 2018 by Zack Dvey-Aharon and Danny Margalit.<ref name="auto3"/><ref name="auto4">{{Cite web |last=Leichman |first=Abigail Klein |date=2023-10-09 |title=11 promising new technologies to help us see better |url=https://www.jpostisrael21c.com/opinionorg/hillelsnew-techtechnologies-cornerto-makinghelp-theus-eyessee-the-windows-of-disease-diagnostics-631998|title=Making the eyes the windows of disease diagnostics|first=Hillel |last=Fuldbetter/ |access-date=July 30,2024-11-18 2020|website=[[TheISRAEL21c Jerusalem Post]]|language=en-US}}</ref> Since its founding, it has received [[investment|funding]] from multiple organizations.<ref>{{Cite webnews|url=https://en.globes.co.il/en/article-biolight-invests-in-1m-in-aeye-health-1001364773|title=BioLight invests in $1m in AEYE Health|date=March 21, 2021|vianewspaper=[[Globes (newspaper)|Globes]]}}</ref>

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).<ref name=":0" /><ref name="auto">{{Cite web|url=https://www.ophthalmologytimes.com/view/aeye-health-reports-results-of-its-ai-algorithm-for-autonomous-screening-and-detection-of-diabetic-retinopathy|title=AEYE Health reports results of its AI algorithm for autonomous screening and detection of diabetic retinopathy|date=February 7, 2022|website=Ophthalmology Times}}</ref><ref name="auto1">{{cite news | url=https://www.reuters.com/business/healthcare-pharmaceuticals/aeye-health-gets-fda-approval-screen-diabetics-prevent-blindness-2022-11-15/ | title=AEYE Health gets FDA approval to screen diabetics to prevent blindness | newspaper=Reuters }}</ref> Utilizing a single image per eye, the AI system demonstrated 93.0 percent sensitivity and 91.4 percent specificity infor detecting referable diabetic retinopathy with over 99 percent [[imageability]] foron the Topcon NW-400 desktop camera. When tested with the Optomed Aurora handheld camera, andit showed 91.9 percent sensitivity, and 93.6 percent specificity with over 99 percent imageability for the Optomed Aurora handheld camera.<ref name="auto" /> In November 2022, AEYE Health received FDA clearance to market its fully autonomous diabetic retinopathy screening system with a [[retinal camera]].<ref name="auto1"/><ref>{{Cite web|url=https://www.ophthalmologytimes.com/view/aeye-health-gains-fda-clearance-to-screen-diabetics-to-head-off-blindness|title=AEYE Health gains FDA clearance to screen diabetics to head off blindness|date=November 15, 2022|website=Ophthalmology Times}}</ref>

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 [[camera|handheld camera]].<ref>{{Cite web|url=https://www.reuters.com/business/healthcare-pharmaceuticals/optomed-oyj-aeye-health-say-portable-device-detect-eye-issues-gets-fda-nod-2024-05-01/|title=Optomed Oyj, AEYE Health say portable device to detect eye issues gets FDA nod &#124; Reuters|website=[[Reuters]] }}</ref><ref name="auto5">{{Cite web|url=https://www.optometrytimes.com/view/aeye-health-receives-fda-clearance-for-first-ever-fully-autonomous-ai-for-portable-dr-screening|title=AEYE Health receives FDA clearance for first ever fully autonomous AI for portable DR screening|date=May 2, 2024|website=Optometry Times}}</ref> The handheld camera is portable, which enables point-of-care screening both in clinics and at home.<ref name="auto5"/>

AEYE Health uses [[artificial intelligence]] to autonomously detect various conditions from retinal images and is compatible with several types of [[retinal camera]]s, including handheld models.<ref name{{cn|date="auto4"/>June 2024}} 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.<ref>{{Cite web|url=https://www.ama-assn.org/practice-management/cpt/cpt-appendix-s-ai-taxonomy-medical-services-procedures|title=CPT Appendix S: AI taxonomy for medical services & procedures|date=June 10, 2024|website=American Medical Association}}</ref>