InfraReDx receives FDA clearance

Coronary imaging developer InfraReDx reported that the U.S. Food and Drug Administration has issued 510(k) clearance for the company to market its near-infrared (NIR) spectroscopic system for examining coronary arteries.

The InfraReDx intracoronary spectroscopy system is a fiber-optic, catheter-based device with a laser light source. The catheter is designed to perform spectroscopy of motion and blood flow in the coronary arteries, according to the Burlington, MA-based company.

By AuntMinnie.com staff writers
October 19, 2006

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