Therapy Areas: Devices
Optina passes US FDA's breakthrough device designation to expedite development of retinal imaging platform for Alzheimer's disease detection
9 May 2019 -

Hyperspectral imaging company Optina Diagnostics revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) breakthrough device designation for its retinal imaging platform (CAPRS1/MHRC2) that uses Artificial Intelligence (AI) to analyse the data rich hyperspectral retinal images captured during a simple eye scan in the diagnosis of Alzheimer's Disease, the most common type of dementia.

The CAPRS1/MHRC2 platform is intended for the detection of likely positron-emission tomography (PET) amyloid status (negative or positive) as well as 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.

Amyloid PET is the standard method for the detection of amyloid plaques in the brain, a key hallmark of Alzheimer's disease.

Following the US FDA's breakthrough device designation, the company is working towards a non-invasive and more accessible means via a simple eye imaging test to improve the diagnosis accuracy and management of patients evaluated for Alzheimer's disease or other form of cognitive decline.

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