Optovue’s iFusion system receives FDA clearance

Fremont, CA-Optovue Inc. has received FDA 510(k) clearance for its new iFusion system, which combines iVue SD-OCT with the recently FDA cleared iCam color fundus camera on a single delivery platform.

iCam is a non-mydriatic 45 degree color fundus camera. The new iFusion system combines OCT and digital fundus photography in one compact, user-friendly platform.

“The iCam and iFusion are the latest achievements in our drive to bring enabling technology to eye-care clinicians everywhere,” said Jay Wei, founder and chief executive officer of Optovue.

The iVue is the compact version of Optovue’s RTVue OCT. iStand is a rolling floor stand option for iVue. When mounted to iStand, patients are able to be scanned in various positions including the supine position. The iCam is a color, non-mydriatic fundus camera offering high quality color images in a simple, compact and affordable device.