Jan 23 2009
OPKO Health, Inc. (NYSE Alternext US:OPK) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to begin marketing in the United States its Spectral OCT SLO Combination Imaging System. Currently marketed internationally by the Company's subsidiary, OPKO Instrumentation, LLC, the Spectral OCT SLO is the product of more than a decade of innovation in the field of combination imaging. High-resolution images are produced with inner retinal choroid and vitreous detail that allow for improved monitoring of ophthalmic disease progression or regression.
"We are pleased to receive 510(k) clearance for the OPKO Spectral OCT SLO Combination Imaging System,” said Jane H. Hsiao, Ph.D., Vice Chairman and Chief Technical Officer of OPKO Health, and President of OPKO Instrumentation. “We believe that the high image quality produced by our Spectral OCT SLO and its versatile user-friendly interface offer the clinician a valuable tool for the detection and visualization of ocular pathologies. In addition, we recently hosted a FDA audit at our facility in Toronto, Canada where we manufacture our Spectral OCT SLO and ultrasound products and are pleased to announce it was accepted without any citation of deficiency after the inspection.”