Home » FDA Grants Clearance for Optina’s Ophthalmic Camera
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.
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