Optina receives breakthrough device designation for retinal imaging platform

The FDA has granted breakthrough device designation to a retinal imaging platform that evaluates patients for Alzheimer’s disease, according to a press release from Optina Diagnostics.
The platform, which consists of a cerebral amyloid predictor retina scan and metabolic hyperspectral retinal camera, uses artificial intelligence to analyze retinal images. It is designed to detect positron-emission tomography amyloid status and assist in the evaluation of adult patients with cognitive impairment.
“Optina Diagnostics’ technology based on data-rich hyperspectral retinal imaging

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