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Novadaq Receives 510(k) Clearance For SPY Endoscopic Imaging System

Novadaq Technologies Inc. announced the SPY endoscopic imaging system has received 510(k) clearance from the US Food and Drug Administration for use during minimally invasive surgery (MIS).

Novadaq’s SPY scope combines the traditional features of a high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures. SPY scope will allow surgeons performing minimally invasive surgeries to simultaneously perform visible light endoscopy and fluorescence visual assessment of blood flow and related tissue perfusion through a single endoscope.

The expansion of our core SPY imaging technology into minimally invasive surgery is a natural progression, and furthers our vision to be the leading imaging company in the operating room, said Dr. Arun Menawat, President and CEO of Novadaq. The MIS market fits perfectly within our growth strategy, as many surgeons using SPY imaging during open access surgeries are also performing MIS procedures. Surgeon opinion leaders propose that SPY scope will positively impact overall minimally invasive surgical success by enabling simultaneous visible and fluorescence imaging assessment in procedures where by design the traditional field of view is limited. We fully expect data will show that SPY scope offers clinical and economic benefits in MIS that are similar to those reported on the use of SPY in open procedures.”