FDA Radiology AI Devices

The OcuMet Beacon is a scanning LED-based ophthalmoscope that captures detailed black and white infrared and autofluorescence images of the human retina. It helps eye care clinicians by providing high-quality retinal images to assist in diagnosis and management of eye conditions, supporting clinical decisions as an adjunctive imaging modality.

MAIA is a medical imaging device used to take detailed digital images of the human retina without the need for pharmacological dilation. It uses confocal imaging and white light illumination to capture sharp, naturally colored retinal images, aiding clinicians in retina examination. The device also features pupil tracking and automatic perimetry for measuring retinal sensitivity and fixation analysis, improving accuracy in eye diagnostics.