AI retinal scanner that can detect Alzheimer's given FDA 'Breakthrough Device' status

A retinal imaging platform that uses artificial intelligence to evaluate eye scans for biomarkers of Alzheimer's disease and other neurological disorders has received the FDA's "Breakthrough Device" designation, Canadian startup Optina Diagnostics announced this week.

The platform uses Optina's cerebral amyloid predictor retina scan and metabolic hyperspectral retinal camera to formulate a data-rich image from a basic eye scan. AI then analyzes the image for indication of amyloid plaques in the brain, which are linked to neurodegenerative diseases such as Alzheimer's.

Optina's technology offers a low-cost, non-invasive way to improve diagnosis accuracy and subsequent care management for patients with cognitive decline, a condition that can often go un- or misdiagnosed.

The FDA's "Breakthrough Device" designation is not a safety approval but provides an expedited pathway for the review of a medical device that the agency believes has the potential to be extremely effective in diagnosing or treating life-threatening diseases.

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