Optina Diagnostics Receives Breakthrough Device Designation from U.S. FDA for a Retinal Imaging Platform to Aid in the Diagnosis of Alzheimer’s Disease
MONTREAL, May 8, 2019 /PRNewswire/ – Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2). Optina Diagnostics’ platform uses Artificial Intelligence (AI) to analyze the data rich hyperspectral retinal images captured with the MHRC during a simple eye scan. Optina Diagnostics’ platform is intended for the detection of likely positron-emission tomography (PET) amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Optina Diagnostics’ platform is an adjunct to other diagnostic evaluations.
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