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New iFusion combination system receives FDA clearance

Article

Optovue Inc. has received FDA 510 (k) clearance for its new iFusion combination system and has begun filing customer orders worldwide.

Fremont, CA-Optovue Inc. has received FDA 510 (k) clearance for its new iFusion combination system and has begun filing customer orders worldwide.

The iFusion system, which began being shipped out July 26, is a unique modular pairing of the iVue SD–OCT and the new iCam non-mydriatic fundus camera on a single delivery platform.

 “The iCam and iFusion are the latest achievements in our drive to bring enabling technology to eye care clinicians everywhere,” said Jay Wei, Optovue Inc. founder and chief executive officer. “We are pleased that once again we have achieved another step through the delivery of iFusion.”

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