Retinal Imaging Platform Granted FDA Breakthrough Device Designation
On May 8, 2019, the US Food and Drug Administration (FDA) granted breakthrough device designation to a retinal imaging platform designed to aid in the detection of Alzheimer’s disease, according to a press release by Optina Diagnostics.
Optina Diagnostics’ platform uses artificial intelligence (AI) to analyze hyperspectral retinal images captured during an eye scan for positron-emission tomography (PET) amyloid status.
Amyloid PET is the standard method for detecting amyloid plaques in the brain—a marker of Alzheimer’s disease—but because the technique is expensive and with limited accessibility, it is not often used in clinical practice.
Optina Diagnostics’ non-invasive platform can be used in conjunction with other diagnostic evaluations to improve the diagnosis accuracy of patients evaluated for Alzheimer’s disease.
“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,” said David Lapointe, CEO, Optina Diagnostics. “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 FDA’s Breakthrough Device Program is designed to accelerate the development and review of medical devices aimed at providing more effective treatment or diagnosis of life-threatening or irreversible debilitating diseases or conditions.
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