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Optina receives breakthrough device designation for retinal imaging platform
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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 combined with AI opens tremendous possibilities to have insights into the brain noninvasively and at a low cost,” David Lapointe, CEO of Optina, said in the release. “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’s disease.”
The platform is designed to be used as an adjunct to other diagnostic evaluations.