August 02, 2013
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Optovue gets FDA clearance for combined SD-OCT, color fundus camera

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The U.S. Food and Drug Administration has granted 510(k) clearance to Optovue for its iFusion combination imaging platform, according to a company news release.

The iFusion offers modular pairing of Optovue’s iVue spectral-domain optical coherence tomography and its iCam non-mydriatic 45° color fundus camera, the release said.

With the FDA clearance, Optovue has begun shipping the iFusion system to customers worldwide, the release said.