OCT combo system receives FDA clearance, begins shipping worldwide

Ophthalmic device maker Optovue has received FDA 510(k) clearance for its iFusion combination system, which pairs the company's iVue spectral-domain optical coherence tomography (SD-OCT) system and iCam non-mydriatic fundus camera.

Ophthalmic device maker Optovue (Fremont, CA) has received FDA 510(k) clearance for its iFusion combination system, which pairs the company's iVue spectral-domain optical coherence tomography (SD-OCT) system and iCam non-mydriatic fundus camera. The company has also begun filling customer orders worldwide for the system, beginning in late July 2013.

Related: In more news for Optovue, FDA approves compact color fundus camera

iFusion combines OCT and digital fundus photography, the two most important imaging modalities in eye care, into one platform for a more comprehensive clinical evaluation.

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

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