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www.fdanews.com/articles/67967-novadaq-receives-fda-clearance-for-spy-imaging-system

Novadaq Receives FDA Clearance for SPY Imaging System

January 25, 2005

Novadaq Technologies' SPY Intra-operative Imaging System has received 510(k) clearance from the FDA for use during Coronary Artery Bypass Surgery (CABG).

The announcement came during the 2005 Society of Thoracic Surgeons Meeting held in Tampa, Fla. The company will begin marketing the system in the U.S. immediately.

The SPY Intra-operative Imaging System is the first fluorescent imaging system available for use during CABG. SPY enables cardiac surgeons to simply and efficiently confirm proper placement of their bypass grafts and assess the functionality of those grafts while the patient is still in the operating room.

Use of Novadaq's SPY Imaging System may potentially reduce the number of patients that must return to the operating room for the revision of improperly functioning or potentially misplaced grafts.