Table 1.

Summary of current AI systems with regulatory approval for different retinal diseases

AI system	Type of application	Year approved	Target disease	Imaging modality	Target user	Regulatory status in the United States, Europe, and elsewhere
Intelligent Retinal Imaging Systems (IRIS; Intelligent Retinal Imaging Systems, Pensacola, FL, USA) [59]	Cloud-based algorithm	2015	Screen for DR	Fundus photography	Healthcare provider	FDA clearance (class II)
Automated Retinal Disease Assessment (ARDA; Google LLC, Mountain View, CA, USA) [60]	Cloud-based algorithm	2016	Screen for referable DR	Fundus photography	Healthcare provider	CE mark
SELENA+ (EyRIS Pte Ltd, Singapore) [61]	Cloud-based algorithm	2019 and 2020	Screen for vision-threatening DR, suspected glaucoma, AMD	Fundus photography	Healthcare provider	CE mark, HAS approval (Singapore)
IDx-DR (Digital Diagnostics Inc., Coralville, IA, USA) [62]	Device and cloud-based algorithm	2018	Screen for referable DR, including DME	Fundus photography	Healthcare provider	FDA approval
Medios AI (Remidio Innovative Solutions Pvt Ltd., Karnataka, India) [63]	Offline AI algorithm	2023	Screening for referable DR and referable glaucoma	Fundus photography from smartphone-based camera	Healthcare provider	CE mark
RetCAD (Thirona Retina BV, Nijmegen, Netherlands) [64]	Cloud-based algorithm	2022	Screen for referable DR, AMD	Fundus photography	Healthcare provider	CE mark
EyeArt (Eyenuk, Inc., Woodland Hills, CA, USA) [65]	Cloud-based algorithm	2015 and 2020	Screen for referable DR	Fundus photography	Healthcare provider	FDA clearance (class II), CE mark
VUNO Med-Fundus AI (VUNO Inc., Seoul, Korea) [66]	Cloud-based algorithm	2020	DR, AMD, glaucoma	Fundus photography	Healthcare provider	CE mark (class IIa), MFDS approval (Korea, class III), HAS approval (Singapore)
THEIA (Toku Eyes, Auckland, New Zealand) [67]	Cloud-based algorithm	2020	Smoking status, AMD, DR, cataract	Fundus photography, OCT-A	Healthcare provider	In progress
iPredict (iHealthScreen Inc., Richmond Hill, NY, USA) [68]	Cloud-based algorithm	2021 and 2022	DR, AMD, glaucoma	Fundus photography, OCT	Healthcare provider	CE mark, TGA approval (Australia)
Notal Home OCT (Notal Vision, Inc., Manassas, VA, USA) [69]	In-home device and cloud-based algorithm	2018	Neovascular AMD	OCT	Patient-driven healthcare	FDA Breakthrough Device Designation
OphtAI (Evolucare/ADCIS, Villers-Bretonneux, France) [70]	Cloud-based algorithm	2019	DR, DME, AMD, glaucoma	Fundus photography	Healthcare provider	CE mark, HC approval (Canada), FDA in progress
Retmarker (Retmarker, SA, Taveiro, Portugal) [71]	Cloud-based algorithm	2010	DR, AMD	Fundus photography	Healthcare provider	CE mark (class IIa), TGA approval (Australia)
RetinaLyze (RetinaLyze System A/S, Hellerup, Denmark) [72]	Cloud-based algorithm	2021	DR, dry AMD, glaucoma	Fundus photography, OCT	Healthcare provider	CE mark (class I, self-certified)
RetinAI Discovery (RetinAI Medical AG, Bern, Switzerland) [73]	Cloud-based algorithm	2022	AMD, DR, DME, RVO	Fundus photography, OCT	Healthcare provider	FDA clearance (class II), CE mark

Note: All medical devices approved by the FDA or accredited by the CE mark from January 2015 to November 2022 were collected. These devices were searched for in the European Database on Medical Devices (EUDAMED) database [74], the FDA website (on the webpage of Artificial Intelligence and Machine Learning-Enabled Medical Devices) [75], and the FDA 510(k) Premarket Notification [76].

ARDA, Automatic Retinal Disease Assessment; DME, diabetic macular edema; HAS, Health Sciences Authority (Singapore); HC, Health Canada; IRIS, Intelligent Retinal Imaging Systems; MFDS, Ministry of Food and Drug Safety (Korea); OCT, optical coherence tomography; OCT-A, optical coherence tomography angiography; RVO, retinal vein occlusion; SELENA, Singapore Eye LEsioN Analyzer; TGA, Therapeutic Goods Administration.