Airway & Respiratory, Industry News

New Study Shows Not All FDA-Cleared Finger Pulse Oximeters Perform Alike

MINNEAPOLIS, May 17, 2016 (PR NEWSWIRE) – Nonin Medical, Inc., the inventor of finger pulse oximetry, today announced the results of a new independent hypoxia lab study in humans that demonstrates that Nonin’s PureSAT® pulse oximetry technology captures and reports worsening patient conditions better than other Food and Drug Administration (FDA)-cleared oximeter brands.* Nonin made the results available in a white paper at the American Thoracic Society (ATS) and American Telemedicine Association (ATA) conferences this week.

In the study, conducted independently by Clinimark Laboratories in Boulder, Colo., three finger pulse oximeters were tested; one from Nonin Medical and two from large, private-labeled manufacturers. All oximeters had FDA 510(k) clearance as “medical devices,” but two of them did not provide the clinical accuracy required to track desaturations in patients with low blood circulation and labored breathing. Only the Nonin Medical oximeter was able to accurately track the desaturation events as compared to an independent hospital tabletop oximeter control device.

“Over the years, a number of inexpensive, imported FDA-cleared oximeters have flooded the market, all claiming to be accurate,” said Jim Russell, vice president of quaIity, regulatory and clinical affairs for Nonin Medical. “This study dispels the myth that all pulse oximeters perform alike, especially on challenging patients such as those with chronic obstructive pulmonary disease (COPD).”

“Clinicians, hospitals and telemedicine providers can better manage COPD patients and potentially reduce readmission rates by choosing pulse oximeters that provide early and accurate data on all patients, including the sickest patients. Nonin Medical’s oximeter performance is proven,” Russell said.
For a copy of the white paper (“Fingertip Pulse Oximeter Performance in Dyspnea and Low Perfusion During Hypoxic Events”), visit Nonin Medical this week at ATA booth #1209 in Minneapolis, ATS booth #1004 in San Francisco, or online at nonin.com/documents/ClinimarkFingertipWhitePaper.pdf.

About Nonin Medical, Inc.
Nonin Medical, Inc. invented the finger pulse oximeter (the original Onyx® brand) and designs and manufactures noninvasive medical monitoring solutions that meet customers’ technology needs today and tomorrow. Headquartered in Plymouth, Minn., USA, with an additional customer service center in Amsterdam, the Netherlands, Nonin Medical sells its pulse and regional oximeters, capnographs, sensors and software to health professionals and consumers in more than 125 countries. The company has more than 300 OEM partners worldwide. For more information, visit nonin.com.

*Source: Batchelder, P.B., Fingertip Pulse Oximeter Performance in Dyspnea and Low Perfusion During Hypoxic Events. Clinimark Laboratories, Boulder, Colorado. 2016. White Paper.