MINNEAPOLIS - Nonin Medical on Tuesday 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-cleared oximeter brands.
Nonin made the results available in a white paper at the American Thoracic Society and American Telemedicine Association conferences this week.
In the study, conducted independently by Clinimark Laboratories, 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," stated Jim Russell, VP quality, 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," he said. "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."