Friday, September 10, 2010 4:11:51 PM
Look what I found.
http://www.medicalnewstoday.com/articles/136637.php
They announced FDA approval for their imaging system on January 26th, 2009 via this PR.
"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."
If they announced FDA approval on January 26th, 2009 and stated that they RECENTLY recieved an FDA audit - that means the FDA audit happen in the past which was before FDA APPROVAL!
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