Table 2.
Extracted 13 CE-certified systems with key metrics
| System | Company | Sensitivity (%) | Specificity (%) | Study type and context | Class | Certification year | Multi-disease | |
|---|---|---|---|---|---|---|---|---|
| IDx-DR | Digital Diagnostics | 90 | 90 | Prospective multicenter trial; primary-care setting; multiple camera models | IIa | 2022 | No | |
| EyeArt | Eyenuk | 94 | 92 | Prospective multicenter; US + EU cohorts; mixed camera types | IIb | 2021 | Yes | |
| RetCAD | Thirona | 86 | 94 | Retrospective EU reader studies; mixed-device image sets | IIa | 2022 | Yes | |
| Mona DR | MONA.health | 95 | 90 | Prospective EU multi-clinic validation; heterogeneous population | IIa | 2023 | No | |
| Remidio Medios AI | Remidio | 92 | 92 | Prospective multicenter, including India + EU; smartphone-based imaging | II | 2023 | No | |
| Retmarker DR | Retmarker | 87 | 94 | Real-world national program (Portugal); longitudinal data | IIa | 2020 | No | |
| SELENA + | EyRIS | 93 | 91 | Multicenter Asia + Europe; real-world deployment | IIa | 2020 | Yes | |
| RetinoScan | TeleMedC | 91 | 90 | Prospective Australia + EU cohorts; cross-camera compatibility | IIb | 2022 | No | |
| Aireen DR | Aireen Technologies | 92 | 91 | Prospective EU primary-care multicenter trial | IIb | 2024 | No | |
| OphthAI | Evolucare/ADCIS | 93 | 92 | Prospective EU + Asia cohorts; multi-camera validation | IIa | 2023 | Yes | |
| LuxIA | LuxIA Diagnostics | 90 | 93 | Technical performance + early EU prospective deployment | IIb | 2025 | No | |
| Airdoc-Eye DR | Airdoc | 91.8 | 93.1 | Large multi-ethnic prospective cohorts; community + real-world settings | IIb | 2024 | Yes | |
| EyeWisdom (Vistel) | Visionary Intelligence | 89–94 | 88–93 | Reader studies; embedded in multimodal fundus-camera platforms; EU deployments | IIa | 2021 | Yes | |