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3-D retinal camera receives 510(k) clearance from FDA
TORRANCE, Calif. — The Kowa Optimed nonmyd WX3D Retinal Camera has received U.S. Food and Drug Administration 510(k) clearance, the company announced in a press release.
The non-mydriatic camera provides the latest in simultaneous stereoscopic photography, with normal and small pupil settings, as well as 2-D and 3-D imaging. The new 3-D technology will help practitioners diagnose glaucoma, the release said.
In addition, the camera connects to Kowa's Digiversal Open Image Management system, allowing practitioners to manage the information collected with the camera.
"By advancing innovation for eye care professionals through the institution of superb imaging technology, practitioners will, in turn, contribute to elevating the quality care for their patients," Dr. Ian Lane, executive vice president of technology at Kowa Optimed, said in the release.
Kowa will begin marketing the diagnostic device in the U.S. immediately.