Clinical UM Guideline

This document addresses retinal telescreening in the outpatient setting, including its use for the detection of diabetic retinopathy.

Note: Please see the following related document for additional information:

• CG-MED-47 Fundus Photography

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Retinal telescreening systems in the outpatient setting are considered medically necessary for annual diabetic retinopathy screening as an alternative to retinopathy screening by an ophthalmologist or optometrist when both of the following criteria are met:

1. The individual does not have prior known diabetic retinopathy; and
2. The imaging and grading technique is performed with a U.S. Food and Drug Administration (FDA) approved device for retinal telescreening.

Not Medically Necessary:

All other uses of retinal telescreening systems in the outpatient setting are considered not medically necessary, including, but not limited to those listed below:

1. To follow the progression of disease in individuals who have been diagnosed with diabetic retinopathy
2. To screen or evaluate retinal conditions other than diabetic retinopathy, including, but not limited to macular degeneration.

This document describes clinical studies and expert recommendations, and explains whether retinal telescreening services are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Retinal telescreening is a way to check for diabetic retinopathy (a diabetes-related eye disease) using special cameras and remote image review. It can be done in a primary doctor’s office instead of an in-person eye exam at the eye doctor’s office. This method is helpful for people with diabetes who do not already have diabetic retinopathy. Retinal telescreening must use FDA approved devices to be considered appropriate. Studies show that telescreening can catch signs of diabetic retinopathy early and help connect people to care before the condition gets worse or causes problems. It is not meant to replace full eye exams for people with known eye disease or to check for other problems like macular degeneration.

What the Studies Show

Telescreening uses special cameras to take pictures of the back of the eye. These images are reviewed either by trained specialists or by computer systems using artificial intelligence (AI). High-quality studies show that telescreening can be nearly as accurate as in-person eye exams by eye doctors for finding diabetic retinopathy. One study showed that people were more likely to get screened when telescreening was available in their primary care office. This can help prevent vision loss by catching problems early. Some systems, like IDx-DR and EyeArt, use AI and have been approved by the FDA. These systems are able to detect vision-threatening diabetic retinopathy with high sensitivity, meaning they catch most cases, although some also report the presence of diabetic retinopathy when it is not present. Telescreening can improve access to care, especially in places where it is hard to see an eye specialist.

When is Retinal Telescreening Clinically Appropriate?

Retinal telescreening may be appropriate in these situations:

• The person has diabetes; and
• Does not already have known diabetic retinopathy; and
• The screening is done using an FDA-approved telescreening device.

When is this not Clinically Appropriate?

Retinal telescreening is not appropriate in these situations:

• To monitor people who already have diabetic retinopathy.
• To check for eye diseases other than diabetic retinopathy, such as macular degeneration.

This test is not clinically appropriate in scenarios other than those listed above. More studies are needed to know if retinal telescreening helps detect or manage other conditions. Using it when not supported by evidence could lead to treatment that does not help or not detecting diseases which are present.

(Return to Description)

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed, or for situations designated in the Clinical Indications section as not medically necessary.

Summary

Retinal telescreening is supported by clinical evidence as an appropriate alternative to in-person eye examinations only for annual screening of diabetic retinopathy in individuals without known disease, when FDA-approved imaging and grading systems are used. Diabetic retinopathy is common, often asymptomatic, and a leading cause of preventable vision loss, yet screening rates remain suboptimal, particularly in underserved populations. Multiple studies demonstrate that teleretinal screening, using trained image acquisition with remote human or FDA-cleared automated interpretation, has high sensitivity for detecting referable and vision-threatening diabetic retinopathy, with acceptable over-referral rates. The American Diabetes Association (ADA) Standards of Care (2026) and the American Academy of Ophthalmology (AAO) support retinal photography with remote interpretation or FDA-approved AI as an effective screening tool when clear referral pathways are in place. Evidence does not support retinal telescreening for monitoring disease progression, detecting diabetic macular edema, or screening for other retinal conditions such as age-related macular degeneration, for which comprehensive ophthalmologic examination remains the standard of care.

Discussion

Background

Diabetic retinopathy is a highly specific vascular complication occurring in type 1 and type 2 diabetes, with the prevalence being highly dependent on disease duration. It is a disorder of the retina that eventually will develop to some extent in nearly all individuals with long-standing type 1 diabetes and over 60% of those with type 2 diabetes. Diabetic retinopathy may be the most frequent cause of new cases of blindness among adults aged 20-74 years in the United States. An estimated 4.1 million Americans are affected by retinopathy with 899,000 affected by vision-threatening retinopathy.

Diabetic retinopathy has few symptoms until vision loss occurs. Ongoing evaluation for retinopathy is of critical importance to allow for early treatment. Despite the high prevalence of the disease, screening rates are suboptimal, only 11-71% of affected individuals in the U.S. receive annual dilated examinations. Screening rates are lower in underserved and minority populations (Ipp, 2021; Patel, 2022). Access to a specialist and the appropriate equipment may not always be available. Retinal telescreening systems have emerged as a way to increase screening for diabetic retinopathy. Because the population of individuals with diabetes mellitus growing more than ten times faster than the number of ophthalmologists worldwide, effective screening methods capable of managing a large volume of individuals will become increasingly important (Weng, 2024).

Screening

The ADA standards of care (2026) recommend a comprehensive eye examination with an ophthalmologist or optometrist within 5 years after diagnosis for adults with type 1 diabetes and at the time of diagnosis for adults with type 2 diabetes. Annual or biennial screening is recommended in the presence of well controlled glycemia when there is no evidence of retinopathy. When any level of diabetic retinopathy is present, screening should be replaced with dilated retinal examinations performed at least annually by an ophthalmologist or optometrist. Recommendations for children and adolescents with diabetes differ slightly as there is a low risk of development of vision-threatening retinal lesions in individuals under the age of 12. For individuals aged 11 or older, or when puberty has started, a comprehensive eye examination is recommended 3 to 5 years following a diagnosis of diabetes. The 2026 ADA recommendations include repeat examinations every 2 to 4 years, depending on the level of risk. The ADA notes that retinal photography, with remote reading or use of an FDA-approved AI algorithm, can be an appropriate screening tool for all age groups. Programs which use retinal photography should include pathways for timely referrals for comprehensive eye examinations when indicated.

An AAO 2024 report evaluated teleretinal screening for both diabetic retinopathy and diabetic macular edema (Weng). The report included studies with varying levels of evidence: level I (n=6), level II (n=9) and level III (n=1) which assessed the accuracy of telescreening in detecting diabetic retinopathy and diabetic macular edema. The report supports that teleretinal screening is effective in detecting diabetic retinopathy and may be used to “complement traditional screening”. When there was a discrepancy in diabetic retinopathy grading between teleretinal screening images and the reference standard, the difference frequently involved an overcall by telescreening within one diabetic retinopathy level, and this tendency to overcall was preferred in screening programs rather than undercalling. The report also concluded:

…the accuracy of TS [telescreening] in detecting more advanced DR [diabetic retinopathy] is better than that for less advanced DR, supporting the ability to use TS as a screening tool supplemented by referrals for in-clinic examination if a certain threshold is met.

The “gold standards” for diabetic retinopathy screening include ophthalmological exam by a trained professional using pupillary dilation and stereoscopic 7-field fundus photography by a trained photographer and interpreted by an experienced grader. In a 2014 Clinical Statement by the AAO for screening individuals for diabetic retinopathy, it is stated that “Appropriately validated digital imaging technology can be a sensitive and effective screening tool to identify patients with diabetic retinopathy for referral for ophthalmic evaluation and management.”

In a 2015 literature review and analysis by Shi and colleagues, 20 articles involving 1960 participants were reviewed to determine the diagnostic accuracy of telemedicine in diabetic retinopathy. In detecting the absence of diabetic retinopathy, low- or high-risk proliferative diabetic retinopathy, the pooled sensitivity was 80%. In the detection of mild or moderate non-proliferative diabetic retinopathy, the sensitivity exceeded 70%. It was also noted that the diagnostic accuracy was higher when the digital images were obtained through mydriasis than through non-mydriasis. While there were some limitations in this literature review, including heterogeneity, 3 of the included studies had unavailable raw data, and the data was only from published papers, the authors concluded that telemedicine can be used widely for diabetic retinopathy screening.

In a 2015 study by Mansberger and colleagues, 567 participants were randomized to receive either telemedicine with a nonmydriatic camera in a primary care clinic (n=296) or traditional surveillance with an eye care professional (n=271) and were followed for 5 years. After 2 years, telemedicine was offered to all participants. During the 6-month or less time period, the telemedicine group participants were more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group (94.6% [280/296] versus 43.9% [119 / 271]; 95% confidence interval [CI], 46.6% - 54.8%; p<0.001). The telemedicine group was also more likely to receive diabetic retinopathy screening exams in the 6- to 18-month timeframe (53.0% [157/296] versus 33.2% [90 / 271]; 95% CI, 16.5% - 23.1%; p<0.001). After 2 years when telemedicine was offered to both groups, there was no difference between the groups in the percentage of diabetic retinopathy screening examinations. These results suggest that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for worsening of disease.

Digital retinal imaging can be obtained by a trained non-physician photographer in the primary care physician’s office, thus obviating the need for separate annual ophthalmology screening for diabetic retinopathy. This may increase an individual’s adherence to annual retinal exams, a critical component of diabetic care. Digital imaging appears to be a highly sensitive test and may be considered an important option for increasing the screening rate. Studies have reported high diagnostic accuracy in identifying diabetic retinopathy via telescreening systems (Bragge, 2011; Date, 2019; Farley, 2008; Fransen, 2002; Ku, 2013; Mehraban Far, 2022; Murgatroyd, 2004; Zimmer-Galler, 2006). It should be noted that retinal telescreening is not a substitute for a comprehensive ophthalmologic examination.

Image grading

Once the digital retinal images are obtained, the grading of the images is done via a manual process by trained retinal specialists, trained readers or automated screening of retinal images. Algorithms have been developed which are capable of reading the digital retinal signals of diabetic retinopathy. One automated system, IDx-DR (Digital Diagnostics Inc., Coralville, IA), has been reviewed and approved by the FDA’s premarket review pathway which is a regulatory pathway for some low- to moderate-risk novel devices for which there is no prior legally marketed device (FDA, 2018). The IDx-DR approval is for detection of greater than a mild level of diabetic retinopathy in adults who have diabetes. In 2022,  the FDA approved  another automated system. AEYE-DS (AEYE Health, Inc., New York, NY) as a substantially equivalent to legally marketed predicate devices. The AEYE-DS clearance is for the automatic detection of more than mild diabetic retinopathy in adults with diabetes who have not been previously diagnosed with diabetic retinopathy, using fundus images acquired with the Topcon NW400 camera.

In a 2018 study by van der Heijden and colleagues, the authors sought to determine how the performance of an automated device compared to retinal specialists when reading digital retinal images. In this study, 3 retinal specialists manually graded the images using the International Clinical Diabetic Retinopathy Severity Scale (ICDR) classification score and the EURODIAB classification systems. The retinal specialists’ scores were then compared to the IDx-DR device. A total of 898 participants had images with sufficient quality for analysis. Using EURODIAB (EUROpe and DIABetes), referable diabetic retinopathy was diagnosed in 22 participants and using ICDR classification, referable diabetic retinopathy was diagnosed in 73 participants. When compared to human grading using EURODIAB, the IDx-DR device showed a sensitivity for referable diabetic retinopathy of 91% (95% CI: 0.69 - 0.98), specificity of 84% (95% CI: 0.81 - 0.86), positive predictive value (PPV) of 12% (95% CI: 0.08 - 0.18) and negative predictive value (NPV) of 100% (95% CI: 0.99 - 1.00). When compared to human grading using the ICDR classification, the IDx-DR system showed a sensitivity of 68% (95% CI: 0.56 - 0.79), specificity of 86% (95% CI: 0.84 - 0.88), PPV of 30% (95% CI: 0.24-0.38), and NPV of 97% (95% CI: 0.95-0.98). Approximately 70% of the retinal images which were classified as referable diabetic retinopathy based on the ICDR score were classified as no referable diabetic retinopathy by the retina specialists when using the EURODIAB score. The study was able to include participants with all possible presentations of diabetic retinopathy. Use of the automated grading system is expected to result in a large reduction in retinal images that require human grading.

In 2020, the FDA granted marketing approval to another automated device, EyeArt (Eyenuk, Inc., Los Angeles, CA). In 2017, Tufail and colleagues evaluated the performance of three automated diabetic retinopathy image assessment systems, Retmarker (not marketed in the US), iGradingM (not marketed in the US) and the EyeArt. In total, 102,856 retinal images from 20,258 consecutive individuals were analyzed. Sensitivity for EyeArt’s ability to detect any retinopathy was 94.7% (95% CI: 94.2 - 95.2%), for referable retinopathy (human graded as either ungradable, maculopathy, preproliferative, or proliferative) was 93.8% (95% CI: 92.9 - 94.6%), and for proliferative retinopathy alone was 99.6% (95% CI: 97.0 - 99.9%). The EyeArt’s specificity was just 20%. Although the specificity was relatively low, the proportion of potentially sight-threatening retinopathy correctly identified was 93.8%, and of the most severe retinopathy (proliferative retinopathy), virtually all cases received the appropriate classification. EyeArt is indicated by the FDA for use:

…by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy.

In 2021, Ipp and associates reported on a multicenter cross-sectional diagnostic study which compared the detection rate of diabetic retinopathy using an AI system against the clinical reference standard. Individuals with diabetes had two digital color fundus photographs (CFP) taken of each eye before undergoing dilatation and CFP imaging by certified staff (n=893). The AI system results were compared against the standard imaging photographs in order to identify more-than-mild diabetic retinopathy (mtmDR) up to vision threatening diabetic retinopathy (vtDR). In the identification of mtmDR, the AI system reported a sensitivity of 95.5% and a specificity of 85.0%. In the identification of vtDR, the AI system reported a sensitivity of 95.1% and a specificity of 89.0%. The study took place in multiple sites including primary care, general ophthalmology and retina specialty centers. Similar sensitivity, specificity, and imageability rates for mtmDR and up to vtDR were reported at the primary care and eye care sites. The authors note that automated AI screening systems can eliminate reported barriers summarizing:

In this study, comparable efficacy was demonstrated by the AI system across primary care and eye care facilities. Therefore, patients can receive prompt, accurate, and consistent detection of mtmDR or vtDR at their facility of choice without specialist involvement. Furthermore, this prompt detection at primary care may help eliminate the disparity in care for patients who live far from eye care specialists. The rapid on-site eye-level DR detection by the AI system enables prompt diagnosis allowing for same-day referral requests for follow-up care, improving the chances of preventing vision loss.

Retinal telescreening for other conditions

The use of teleretinal screening programs has been evaluated for other retinal diseases. A systematic review and meta-analysis by Mehraban Far and associates (2022) compared the diagnostic accuracy of teleretinal screening and face-to-face examination in either diabetic retinopathy or age-related macular degeneration (AMD). In the three studies (n=697) evaluating the diagnostic accuracy of telescreening for AMD, the calculated sensitivity was 0.71 (95% CI: 0.49 to 0.86) and the calculated specificity was 0.88 (95% CI: 0.85 to 0.90). While the initial results may be encouraging, the current body of evidence has not shown that teleretinal screening is an accurate tool similar to a traditional office-based examination for AMD. Furthermore, routine screening of visual acuity, including for causes such as AMD, is not generally in accordance with standards of medical practice, whether in an office-based setting, or through teleretinal screening.

The 2024 AAO report (Weng) regarding teleretinal screening for diabetic retinopathy and diabetic macular edema, reported sufficient diagnostic accuracy in detecting diabetic retinopathy, but not for diabetic macular edema. Telescreening is less effective for detecting diabetic macular edema; with research on this capability being limited. The document recommends that further research focus on integrating advanced technologies such as AI and enhancing imaging techniques to improve the detection and management of diabetic macular edema. While teleretinal screening for diabetic macular edema could potentially become a viable alternative to traditional screening, advancements are necessary to bolster its effectiveness in this condition.

Screening recommendations

In 2015, an estimated 2.91 million individuals aged 60 or older were living with impaired visual acuity (best corrected visual acuity (BCVA) worse than 20/40 but better than 20/200). An additional 760,000 individuals were living with blindness (BCVA of 20/200 or worse). There is limited evidence to support screening for visual impairment in asymptomatic older adults. The United States Preventive Services Task Force (USPSTF) and the Canadian Task Force on Preventive Health Care (CTFPHC) do not recommend screening for impaired vision in adults aged 65 and older without vision problems or risk factors for impaired vision (USPSTF, 2022; Wilson, 2018).

The 2025 AAO preferred practice patterns (PPP) for diabetic retinopathy note that the following:

The purpose of an effective screening program for DR is to determine who needs a referral to an ophthalmologist for close follow-up or to an ophthalmologist with retinal experience for treatment and who may simply be screened annually.

The PPP recommends a specific schedule for individuals with diabetes mellitus and no diabetic retinopathy.

* Abnormal findings may dictate frequent follow-up examinations.
† Pubertal patients require increased vigilance due to increased risk of progression.
‡ Women who develop gestational diabetes do not require an eye examination during pregnancy and do not
appear to be at increased risk for DR during pregnancy

Comprehensive medical eye examinations serve to detect ocular disease, visual dysfunction, or ophthalmic signs of systemic disease at a treatable stage in order to prevent or slow the progression of disease and preserve visual function. Eye examinations can lead to the diagnosis of systemic disease, possibly preventing serious illness or premature death.

Peer Reviewed Publications:

1. Bragge P, Gruen RL, Chau M, et al. Screening for presence or absence of diabetic retinopathy: a meta-analysis. Arch Ophthalmol. 2011; 129(4):435-444.
2. Date RC, Shen KL, Shah BM, et al. Accuracy of detection and grading of diabetic retinopathy and diabetic macular edema using teleretinal screening. Ophthalmol Retina. 2019; 3(4):343-349.
3. Farley TF, Mandava N, Prall FR, Carsky C. Accuracy of primary care clinicians in screening for diabetic retinopathy using single-image retinal photography. Ann Fam Med. 2008; 6(5):428-434.
4. Fransen SR, Leonard-Martin TC, Feuer WJ, et al. Clinical evaluation of patients with diabetic retinopathy: accuracy of the Inoveon diabetic retinopathy-3DT system. Ophthalmology. 2002; 109(3):595-601.
5. Ipp E, Liljenquist D, Bode B, et al.; EyeArt Study Group. Pivotal evaluation of an artificial intelligence system for autonomous detection of referrable and vision-threatening diabetic retinopathy. JAMA Netw Open. 2021; 4(11):e2134254.
6. Ku JJ, Landers J, Henderson T, Craig JE. The reliability of single-field fundus photography in screening for diabetic retinopathy: the Central Australian Ocular Health Study. Med J Aust. 2013; 198(2):93-96.
7. Lim JI, Labree L, Nichols T, et al. Comparison of nonmydriatic digitized video fundus images with standard 35-mm slides to screen for and identify specific lesions of age-related macular degeneration. Retina. 2002; 22(1):59-64.
8. Mansberger SL, Sheppler C, Barker G, et al. Long-term comparative effectiveness of telemedicine in providing diabetic retinopathy screening examinations: a randomized clinical trial. JAMA Ophthalmol. 2015; 133(5):518-525.
9. Mehraban Far P, Tai F, Ogunbameru A, et al. Diagnostic accuracy of teleretinal screening for detection of diabetic retinopathy and age-related macular degeneration: a systematic review and meta-analysis. BMJ Open Ophthalmol. 2022; 7(1):e000915.
10. Murgatroyd H, Ellingford A, Cox A, et al. Effect of mydriasis and different field strategies on digital image screening of diabetic eye disease. Br J Ophthalmol. 2004; 88(7):920-924.
11. Osareh A, Mirmehdi M, Thomas B, et al. Automated identification of diabetic retinal exudates in digital color images. Br J Ophthalmol. 2003; 87(10):1220-1223.
12. Patel D, Ananthakrishnan A, Lin T, et al. Social determinants of health and impact on screening, prevalence, and management of diabetic retinopathy in adults: a narrative review. J Clin Med. 2022; 11(23):7120.
13. Rudnisky CJ, Hinz BJ, Tennant MTS, et al. High-resolution stereoscopic digital fundus photography versus contact lens biomicroscopy for the detection of clinically significant macular edema. Ophthalmology. 2002; 109(2):267-274.
14. Saari JM, Summanen P, Kivela T, Saari KM. Sensitivity and specificity of digital retinal images in grading diabetic retinopathy. Acta Ophthalmol Scand. 2004; 82(2):126-130.
15. Shi L, Wu H, Dong J, et al. Telemedicine for detecting diabetic retinopathy: a systematic review and meta-analysis. Br J Ophthalmol. 2015; 99(6):823-831.
16. Thomas CG, Channa R, Prichett L, et al. Racial/ethnic disparities and barriers to diabetic retinopathy screening in youths. JAMA Ophthalmol. 2021; 139(7):791-795.
17. Tu KL, Palimar P, Sen S, et al. Comparison of optometry vs. digital photography screening for diabetic retinopathy in a single district. Eye (Lond). 2004; 18(1):3-8.
18. Tufail A, Kapetanakis VV, Salas-Vega S, et al. An observational study to assess if automated diabetic retinopathy image assessment software can replace one or more steps of manual imaging grading and to determine their cost-effectiveness. Health Technol Assess. 2016; 20(92):1-72.
19. Tufail A, Rudisill C, Egan C, et al. Automated diabetic retinopathy image assessment software: diagnostic accuracy and cost-effectiveness compared with human graders. Ophthalmology. 2017; 124(3):343-351.
20. van der Heijden AA, Abramoff MD, Verbraak F, et al. Validation of automated screening for referable diabetic retinopathy with the IDx-DR device in the Hoorn Diabetes Care System. Acta Ophthalmol. 2018; 96(1):63-68.
21. Van Leeuwen R, Chakravarthy U, Vingerling JR, et al. Grading of age-related maculopathy for epidemiological studies: is digital imaging as good as 35-mm film? Ophthalmology. 2003; 110(8):1540-1544.
22. Whited JD. Accuracy and reliability of teleophthalmology for diagnosing diabetic retinopathy and macular edema: a review of the literature. Diabetes Technol Ther. 2006; 8(1):102-111.
23. Zimmer-Galler I, Zeimer R. Results of implementation of the DigiScope for diabetic retinopathy assessment in the primary care environment. Telemed J E Health. 2006; 12(2):89-98.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Diabetes Association Professional Practice Committee. 12. Retinopathy, neuropathy, and foot care: standards of care in diabetes-2026. Diabetes Care. 2026; 49(Supplement_1):S261-S267.
2. American Diabetes Association Professional Practice Committee. 14. Children and adolescents: standards of care in diabetes-2026. Diabetes Care. 2026; 49(Supplement_1):S297-S320.
3. Chuck RS, Dunn SP, Flaxel CJ, et al.; American Academy of Ophthalmology Preferred Practice Pattern Committee. Comprehensive adult medical eye evaluation preferred practice pattern^®. Ophthalmology. 2021; 128(1):P1-P29.
4. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic retinopathy preferred practice pattern^®. Ophthalmology. 2020; 127(1):P66-P145. Erratum in: Ophthalmology. 2020; 127(9):1279.
5. Lim JI, Kim SJ, Bailey ST, et al.; American Academy of Ophthalmology Preferred Practice Pattern Retina/Vitreous Committee. Diabetic retinopathy preferred practice pattern^®. Ophthalmology. 2025; 132(4):P75-P162.
6. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Rockville, MD:FDA. Accessed on January 22, 2026.
   • AEYE-DS Retinal Diagnostic Software Device. No. K221183. November 10, 2022. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221183.pdf.
   • Digiscope ophthalmic camera. No. K990205. March 26, 1999. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k990205.pdf.
   • EyeArt. Eyenuk, Inc., Los Angeles, CA. No. K200667. August 03, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200667.pdf.
   • IDx-DR. Digital Diagnostics Inc. Coralville, IA. No. K203629. June 1, 2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203629.pdf.
7. US Preventive Services Task Force; Mangione CM, Barry MJ, Nicholson WK, et al. Screening for impaired visual acuity in older adults: US Preventive Services Task Force recommendation statement. JAMA. 2022; 327(21):2123-2128.
8. Weng CY, Maguire MG, Flaxel CJ, et al. Effectiveness of conventional digital fundus photography-based teleretinal screening for diabetic retinopathy and diabetic macular edema: a report by the American Academy of Ophthalmology. Ophthalmology. 2024; 131(8):927-942.
9. Wilson BJ, Courage S, Bacchus M, et al.; Canadian Task Force on Preventive Health Care. Screening for impaired vision in community-dwelling adults aged 65 years and older in primary care settings. CMAJ. 2018; 190(19):E588-E594.

AEYE-DS (AEYE Health, New York, NY)
Diabetic Retinopathy
DigiScope Ophthalmic Camera
Digital Fundus Photography
EyeArt^® system (Eyenuk, Inc., Woodland Hills, CA)
Fundus Photography, Digital
IDx-DR
LumeneticsCore^™ (Digital Diagnostics Inc., Coralville, IA)
Retinal Telescreening
Teleretinal Screening
VISUPAC^™ Digital Imaging System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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