Avinger Inc (AVGR)

[jmoney360]

$AVGR,REDWOOD CITY, Calif., May 23, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease. Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. Peripheral artery disease is projected to affect more than 21 million people in the United States alone by 2020. $AVGR,this FDA clearance is MAJOR NEWS
All manufacturers who seek to market medical devices in the United States must first pass a very thorough process with the FDA through one of two pathways—the section 510(k) process, where a device is “cleared” for distribution, or the Premarket Approval (PMA) process, where a device is “approved” by the FDA.