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Retinal imaging platform wins FDA breakthrough designation

American Academy of Ophthalmology News May 16, 2019

Optina Diagnostics has received the breakthrough device designation from the US Food and Drug Administration (FDA) for their retinal scanner designed to aid in the early detection of Alzheimer disease.

The platform utilizes artificial intelligence to identify beta-amyloid (AB) plaques—a key biomarker of Alzheimer disease—from simple eye scans. Optina hopes their approach will offer an inexpensive and convenient alternative to amyloid PET scans, and a higher diagnostic accuracy than using clinical symptoms.

"Optina Diagnostics' technology based on data-rich hyperspectral retinal imaging combined with AI opens tremendous possibilities to have insights into the brain non-invasively and at a low cost,” explained the company’s CEO, David Lapointe. “The Optina Diagnostics technology could also be helpful to accelerate and reduce the cost for the enrollment of participants that are really on the Alzheimer's path to conduct clinical trials for disease-modifying drugs for Alzheimer disease.”

The Montreal-based company sees their platform as an adjunct to other diagnostic methods for evaluating Alzheimer disease and other causes of cognitive decline.

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