Device Tracker
FDA-Cleared AI Devices in Primary Care and Laboratory
Point-of-care testing and screening tools designed to run outside a specialist setting.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| Retinal Screening in Primary Care | Multiple manufacturers | Varies | Ongoing | Retinal photography | Autonomous retinal screening deployed outside eye clinics |
| Sight OLO | Sight Diagnostics | 510(k) | 2019 | Digital microscopy | Point-of-care complete blood count from a finger prick |