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Novadaq's SPY tech labelling:

This article was originally published in Clinica

Executive Summary

The US FDA has given Novadaq Technologies 510(k) clearance to revise the labelling of its SPY intra-operative imaging system, a fluorescence-based guided technology that enables cardiac surgeons to visually assess coronary vasculature and bypass graft functionality during open-heart bypass surgery. The revision allows direct injection of the imaging agent to the vessels in the region of interest, giving the surgeon greater flexibility without posing any additional risk to the patient, said the Toronto, Canada firm. In addition, the company has also begun two additional clinical trials in different therapeutic applications for SPY - cerebral angiography during neurosurgery and the evaluation of access points for renal failure patients undergoing haemodialysis. Applying the imaging platform to different therapeutic areas, with no significant investment in technology, demonstrates the potential to expand the market opportunity for Novadaq, the firm said.

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