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# AI Optics Handheld Retinal Imager Cleared
- URL: https://www.fdaweb.com/ai-optics-handheld-retinal-imager-cleared/
- Published: 2025-01-28T12:00:00.000Z
- Updated: 2026-09-14T14:51:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158557

FDA has cleared an AI Optics 510(k) for its [Sentinel Camera](https://c212.net/c/link/?t=0&l=en&o=4349487-1&h=4259922206&u=https%3A%2F%2Fwww.aioptics.ai%2Fsentinel-camera&a=Sentinel+Camera&ref=fdaweb.com), a handheld retinal imaging device for capturing images of the human eye. The AI Optics says the camera is intended for use at point-of-care facilities (general/primary healthcare providers) to eliminate the need for visiting an eye specialist’s office. The device has a built-in image processor that captures color and infrared retinal images. AI Optics says it is also developing AI-based retinal screening software for future integration, which will provide a comprehensive end-to-end solution for detecting retinal diseases like diabetic retinopathy, glaucoma, and macular degeneration.