Nonin Medical, Inc. Announces FDA 510(k) Clearance Expanded Labeling for Onyx® Vantage 9590 Professi





Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced commercial release with expanded labeling claims for its Onyx® Vantage 9590 professional fingertip pulse oximeter. The new labeling allows the Onyx Vantage to be used on thumbs and toes – an addition to a previous indication for fingertips – on pediatric through adult patients whose digit diameters range from 0.3 inches to 1.0 inches. Nonin Medical made the announcement at the American Thoracic Society (ATS) 2012 Annual Meeting in San Francisco. The Onyx Vantage accurately captures oxygen saturation (SpO2) and pulse rate measurements even in the presence of low perfusion and dark skin pigmentation. It is the first and only fingertip pulse oximeter with accuracy claims for expanded use on thumbs and toes.
“Nonin’s Onyx brand of professional finger pulse oximeters is already proven accurate in the widest range of patients and settings,” said Kevin McGowan, vice president, global sales, for Nonin Medical. “With this expanded indication, clinicians will now be able to use Nonin’s newest professional pulse oximeter, the Onyx Vantage 9590, on fingers, thumbs or toes. This gives them even more flexibility to obtain accurate readings on a wide range of patients from pediatrics through adults.
“No longer will clinicians have to trade flexibility for peace of mind,” McGowan added. “That’s because, regardless of which digit they use, they can be assured that they are getting accurate readings for improved decision making that may lead to earlier intervention and better outcomes.”
The Onyx Vantage finger pulse oximeter is engineered with Nonin Medical’s clinically proven PureSAT™ pulse oximetry technology – the same accurate technology used in its full line of oximeters. Peer-reviewed articles about Nonin’s proven accuracy can be found online at www.onyxvantage.com.
The Onyx Vantage 9590, along with Nonin’s complete line of professional wrist-worn, handheld and tabletop pulse oximeters, sensors and capnographs, can be viewed at Nonin Medical Booth #516, Moscone Center, San Francisco, during ATS Annual Meeting exhibit hours on Monday, May 21, from 10am-3pm, and Tuesday, May 22, from 10am-3pm.
 
About Nonin Medical, Inc.
Nonin Medical, Inc. invented finger pulse oximetry and designs and manufacturers innovative noninvasive medical monitoring solutions. Headquartered in Plymouth, Minn. with an additional distribution and service center in Hudiksvall, Sweden, Nonin distributes its pulse and cerebral oximeters, capnographs, sensors and software to health professionals and consumers in more than 125 countries. The company has more than 100 OEM partners worldwide.
Nonin Medical leads the industry in remote monitoring by providing cost-effective, accurate devices that enable open data exchanges. A founding member of the Continua Health Alliance and a Bluetooth SIG CES Award winner, Nonin Medical is dedicated to developing easy-to-integrate, low power, interoperable technology to reduce healthcare costs and improve quality of life. Since launching the world’s first Continua™-Certified product in 2009 (the Onyx II 9560), the company continues to drive global connectivity standards and add interoperable solutions across its product line. For more information, visit www.nonin.com