Angiology
Luna Innovations Submits FDA 510(k) Application for EDAC QUANTIFIER Monitor
Published in Medical Letter on the CDC and FDA, May 20th, 2007
Luna Innovations (NASDAQ: LUNA) announced that it has submitted its 510(k) application to the U.S. Food and Drug Administration for the EDAC(TM) (Emboli Detection and Classification) QUANTIFIER. This innovative medical device uses quantitative ultrasound technology to non-invasively count and measure gaseous emboli in the extracorporeal blood circuits. FDA clearance would enable Luna Innovations to market and sell the EDAC QUANTIFIER for clinical use in the United States.
The EDAC QUANTIFIER represents a breakthrough in cardiothoracic surgery. The instrument is designed to reliably detect harmful gaseous emboli during open-heart surgery. Gaseous emboli are air bubbles...
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