iFusion receives FDA clearance and begins shipping world-wide
The new iFusion combination of iVue SD-OCT and the recently FDA cleared iCam color fundus camera has received FDA clearance and is now shipping to customers world-wide.
Optovue Inc. reports that the company has received FDA 510(k) clearance for its new iFusion combination system and has begun filling customer orders world-wide. The iFusion system is the unique modular pairing of the iVue SD-OCT and the new iCam non-mydriatic fundus camera on a single delivery platform. iFusion units began shipping on Friday, July 26th.
Optovue recently received FDA clearance for iCam, a non-mydriatic 45 degree color fundus camera. Its quality image, ease of use, portability, and affordability makes iCam the ideal fundus camera solution for most eye care practices world-wide.
The new iFusion system combines OCT and digital fundus photography, the two most important imaging modalities in eye care, into one easy-to-use platform for a more comprehensive clinical evaluation. This combination is Optovue’s next step in its vision of bringing the most innovative imaging solutions to the broad spectrum of eye care.
“The iCam and iFusion are the latest achievements in our drive to bring enabling technology to eye care clinicians everywhere,” stated Jay Wei, company founder and CEO. “We are pleased that once again we have achieved another step through the delivery of iFusion.”
About RTVue®, iVue®, iStand™ and iCam™
RTVue was the first FDA-cleared Spectral-Domain OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician. 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.
About Optovue® (www.optovue.com)
Optovue Inc. is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Encinitas, CA and European operations in Dossenheim, Germany. For more information, visit www.optovue.com.