SystemAIS-001Medical device and SaMD
Retinal Screening Assistant
Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.
Device class
Class IIa (MDR)
FDA
Class II, 510(k)
EU AI Act
High-risk (Annex I)
- Status
- Approved for operation
- State
- Deployed
- Owner
- Cirocco Jones
- Readiness
- 0
- Blockers
- 12
Monitoring does not stop when an AI System is approved. A signal opens a finding, and a breach can place the AI System under restriction before anyone opens a form.
Scout is watching
2 signals open, 1 of which propose restriction of this AI System.
Open signals
Ordered as received. Nothing closes itself.
| Observed | Type | Signal | Severity | |
|---|---|---|---|---|
| 2026-07-01 | Performance | Sensitivity below threshold, northern sites Sensitivity 0.88 against a floor of 0.92 across four northern sites over the July window. Restriction of the AI System is proposed. | Blocker | |
| 2026-07-01 | Drift | Image statistics drift above tolerance Population drift metric 0.21 against a tolerance of 0.15, coincident with a camera fleet replacement at two sites. | Blocker |
Answered
Kept, because the response is part of the record.
| Observed | Type | Signal |
|---|---|---|
| 2026-07-18 | Complaint | Clinician reports repeated ungradable classification |