Optina Diagnostics announced today that it received FDA 510(k) clearance for its Mydriatic Hyperspectral Retinal Camera (MHRC-C1).
The Montreal-based company’s ophthalmic camera captures images of the retina at multiple wavelengths under mydriatic conditions to provide eye care practitioners with a series of monochromatic images obtained in less than one second, according to a news release.
Optina Diagnostics develops a retinal deep phenotyping platform that combines data-rich hyperspectral retinal imaging and artificial intelligence, which received FDA breakthrough device designation last year. The company said in a news release that the FDA clearance of its MHRC-C1 camera is the first step toward progressing the development of the platform.
“We are excited about the 510k clearance from the FDA,” Optina Diagnostics CEO David Lapointe said in the release. “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.”