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The Food and Drug Administration (USA) provides Optina Diagnostics with breakthrough device designation for a new Retinal Imaging Platform

Wednesday 08 May 2019

On 8 May, the American Food and Drug Administration provided the biotech company Optina Diagnostics with the esteemed breakthrough device designation for a Retinal Imaging Platform that aspires to aid in the diagnosis of Alzheimer’s disease (AD).

There is a rising interest in the identification of people at early or even preclinical stages of dementia. Recent findings have underpinned the potential value of eye scans to support diagnosis of AD and dementia. The motivation for this focus is intensified because researchers seek to administer drugs that may slow or halt progression of toxic build-ups in the brains of people affected before their brains are negatively affected. In this context, efficient and successful identification of people at early stages of the disease course is seen as co-dependent with the successful development of still lacking treatments. The Optina Diagnostics platform uses Artificial Intelligence on eye scans that are captured with the Metabolic Hyperspectral Retinal Camera and the Cerebral Amyloid Predictor Retina Scan. The press release can be read here:

https://www.prnewswire.com/news-releases/optina-diagnostics-receives-breakthrough-device-designation-from-us-fda-for-a-retinal-imaging-platform-to-aid-in-the-diagnosis-of-alzheimers-disease-300846450.html

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