FDA Grants Clearance for Optina’s Ophthalmic Camera

The FDA has granted Optina Diagnostics 510(k) clearance for its Mydriatic Hyperspectral Retinal Camera, MHRC-C1.

The camera is designed to take images of a patient’s retina at multiple wavelengths while the pupil is dilated and is a part of the company’s Retinal Deep Phenotyping platform, which it is developing for use in assessing cognitive impairment due to Alzheimer’s and other conditions.

MHRC-C1 is able to capture a series of monochromatic images of the retina in under one second, which can be used in assessments by eye care practitioners, Optina said.