Optina Diagnostics receives 510(k) clearance from U.S. FDA for its MHRC-C1, permitting hyperspectral imaging of the retina
Optina Diagnostics announces today that it received 510(k) clearance for its ophthalmic camera (MHRC-C1) by the U.S. Food and Drug Administration (FDA).
May 13, 2020
MONTRÉAL, QUÉBEC, CANADA — Optina Diagnostics announces today that it received 510(k) clearance for its ophthalmic camera, the Mydriatic Hyperspectral Retinal Camera (MHRC-C1), by the U.S. Food and Drug Administration (FDA). The MHRC-C1 is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions. The camera provides eye care practitioners with a series of monochromatic images obtained in less than 1 second.
Optina Diagnostics is committed to continue the development of its Retinal Deep Phenotyping platform, combining data-rich hyperspectral retinal imaging and artificial intelligence (AI) to better characterize Brain Health. The 510(k) clearance of the MHRC-C1 is the first step towards this goal, as it will allow the engagement of eye clinics and the development of clinical ecosystems to pursue clinical studies. Optina’s Retinal Deep Phenotyping platform obtained FDA Breakthrough Device Designation in April 2019. The first application under development is for the detection of positron-emission tomography (PET) amyloid status (negative or positive), to aid in the assessment of adult patients with cognitive impairment due to Alzheimer’s disease or other conditions.
“We are excited about the 510k clearance from the FDA. This represents a key milestone in our development program and brings us one step closer to our goal of changing mindsets when it comes to Brain Health. We look forward to future developments and bringing new diagnostic tools to clinicians, patients, and families, who are entitled to better supportive information that will guide better patient care.” said David Lapointe, CEO of Optina Diagnostics.
About Optina Diagnostics
Optina Diagnostics is a Montreal-based company focused on changing mindsets when it comes to Brain Health. With a first application in the early diagnosis of Alzheimer’s, Optina challenges the status quo by providing an accurate, simple, and non-invasive optical test to understand the age-related sources of cognitive decline, empowering millions. optinadx.com
1. The use of the MHRC-C1 for any clinical application other than the currently approved intended use should be conducted under research protocol.