Topcon receives FDA approval for OCT technology

Paramus, NJ-Topcon Medical Systems Inc. has received FDA approval for technology that combines Fourier-domain optical coherence tomography (OCT) with a color, non-mydriatic retinal camera. The equipment (3D OCT-1000) is the first of its kind, according to the company.

The instrument provides high-resolution, cross-sectional imaging of the retina to assist in the diagnosis and monitoring of pathologies such as retinal detachments, macular holes, age-related macular degeneration, and glaucoma. Among its features are a three-dimensional view of the mapped area and retinal registration of the OCT image and the fundus image.

“By offering a greater number of scans over a large area, the . . . data [from the new technology] provide better delineation of pathology and accurate retinal registration and color fundus images, enabling a more precise comparison of OCT data between patient visits,” said Alexander Walsh, MD, assistant professor of ophthalmology, Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles. “It also allows the practitioner to map the exact location of retinal abnormalities, many of which cannot even be seen with time-domain OCT, and enhances visualization for the purpose of patient education.”

The company has sold more than 300 of the devices outside of the United States, said Paul Iwasaki, president of Topcon Medical Systems. “We are now happy to have the instrument available for our U.S. customers,” he added.