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The U.S. Food and Drug Administration this month granted Breakthrough Device Designation to a system designed to make Alzheimer’s evaluations via a noninvasive eye scan.
Optina Diagnostics’ device uses artificial intelligence to crunch data from proprietary scans that can detect markers that correlate with amyloid plaques, sticky clumps of protein that build up in the brains of Alzheimer’s patients.
This will give medical professionals quick clues about the presence of Alzheimer’s.
The FDA’s Breakthrough Device Designation is intended to speed the time to market of treatments that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
“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 U.S.,” said Optina David Lapointe in a statement.
Clinical trials of the process will begin soon, Optina Chief Information Officer Claudia Chevrefils told us, and the company plans to bring the device to market within the next two to three years.
Montreal-based Optina was 2014. In October 2018, the company announced it had raised $4 million in seed funding.
