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FoxHollow seek US nod for NightHawk:

This article was originally published in Clinica

Executive Summary

FoxHollow Technologies has submitted to the US FDA a 510(k) marketing application for its NightHawk system for visualising and excising plaque from peripheral arteries. The product brings together optical coherence tomography (OCT) with the firm's FDA-cleared SilverHawk plaque excision system. It uses fibre-optic technology embedded in the catheter and allows the physician to visualise in real-time the vascular morphology and wall structures. The OCT-embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures. Separately, the Redwood City, California firm has launched a faster and easier-to-use version of SilverHawk, called SilverHawk SXL.

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