Regulatory News

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

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. 

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.