LAKE SUCCESS, N.Y.--(BUSINESS WIRE)--E-Z-EM, Inc. (Nasdaq:EZEM) announced the formal launch of the Company’s new EZ CHEMTM blood analyzer, a convenient point-of-care device for conducting blood assays in patients prior to certain imaging procedures. Nova Biomedical—the Company’s development partner for EZ CHEM—submitted a 510(k) application for the base technology, under the product name StatSensorTM, to the US Food and Drug Administration (FDA) in January 2007. Nova received FDA clearance for StatSensor in May 2007. Nova has since completed all remaining regulatory and engineering requirements for EZ CHEM, including the preparation and filing of all necessary documentation, and the product is now cleared for sale in the US. The Company expects to begin shipping initial units to select clinical sites in the coming weeks.
