July 02, 2007
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Topcon receives FDA approval for its 3D OCT-1000 system

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PARAMUS, N.J. — Topcon Medical Systems has received U.S. Food and Drug Administration approval for its 3D OCT-1000 Fourier-domain optical coherence tomography system, the company announced in a press release.

The device, which is combined with a color non-mydriatic retinal camera, creates true 3-D views of the mapped area. It also provides accurate pinpoint retinal registration of the OCT image and the fundus image, the release said.

The Topcon 3D OCT also measures 100% of the mapped area, compared with less than 5% with conventional time-domain OCT, according to Alexander Walsh, MD, assistant professor of ophthalmology at the Doheny Eye Institute.

"With time domain instruments, errors are propagated across a large area, and the instrument may miss small lesions that fall between the lines. By offering a greater number of scans over a large area, the 3D OCT data provides better delineation of pathology and accurate retinal registration and color fundus images, enabling a more precise comparison of OCT data between patient visits," he said in the release.

The 3D OCT also allows for the exact location of retinal abnormalities to be mapped, "many of which cannot even be seen with time domain OCT, and enhances visualization for the purpose of patient education," he said.