Optina Diagnostics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its retinal imaging platform (CAPRS / MHRC) to help in the diagnosis of Alzheimer's disease.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
CAPRS is a cerebral amyloid predictor retina scan, while MHRC is a metabolic hyperspectral retinal camera.
The company’s platform uses artificial intelligence (AI) to assess data rich hyperspectral retinal images captured with the MHRC during a simple eye scan.
The platform has been develop to help detect likely positron-emission tomography (PET) amyloid status, including negative or positive, to assist in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
According to Optina, the company’s platform is an adjunct to other diagnostic evaluations.
Amyloid PET is the standard method to detect amyloid plaques in the brain, and it helps in confirming the diagnosis and optimize the patient management of patients being assessed of Alzheimer’s disease and other causes of cognitive decline.
Amyloid PET is said to be an expensive technique of limited accessibility.
Optina also noted that it is working towards a non-invasive and more accessible means through a simple eye imaging test to enhance the diagnosis accuracy and management of patients assessed for Alzheimer’s disease or other form of cognitive decline.
Optina Diagnostics CEO David Lapointe said: “We are excited to receive this Breakthrough Device Designation from the FDA as it recognizes the potential benefits the Optina Diagnostics’ platform could bring to clinicians, their patients and families in the diagnosis of Alzheimer’s disease and will permit to expedite its development and regulatory approval in the US.
“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.”
Montreal-based Optina Diagnostics is involved in the development of technology for the early detection of diseases through hyperspectral imaging of the retina. The firm applies an AI approach to biomarker detection for the early diagnosis of Alzheimer’s disease.