Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter
Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced that the Food and Drug Administration (FDA) has cleared the Nonin Model 3231 OEM/eHealth finger pulse oximeter for use in the United States. The finger pulse oximeter plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. The Model 3231 received EU certification last year.
"Leading telemedicine providers such as HealthSpot and Bosch Healthcare have chosen to integrate the Nonin 3231 into their telehealth systems because they expect the 3231 to provide superior performance in the widest patient population, including challenging patients."
"Unlike some imported oximeters, Nonin's American-made Model 3231 is a medical device with clinically proven accuracy, not a health and wellness gadget," VanderWerf said. "This is important to telemedicine providers because they are measuring and guiding decisions on real patients with real diagnosed diseases such as COPD, CHF and asthma. They depend on the clinical accuracy of a real medical device," VanderWerf said.
The Model 3231 features accuracy advantages, including:
- Nonin's clinically proven PureSAT® Pulse Oximetry (SpO2) technology, which utilizes intelligent pulse-by-pulse filtering to provide precise oximetry measurements—even in the presence of motion, dark skin tones, low perfusion, rapid SpO2 changes and other challenging conditions. PureSAT automatically adjusts to each patient's condition to provide fast and reliable readings that clinicians can act on.
- Exclusive Nonin CorrectCheck™ technology, which provides feedback via a digital display if the patient's finger is not placed correctly in the device. CorrectCheck is helpful since improper finger placement may lead to incorrect readings.
- SmartPoint™ capture, an algorithm developed by Nonin that automatically determines when a high quality measurement is ready to be stored. This helps to ensure that each reading transmitted by the Model 3231 is accurate.
Nonin received FDA clearance in September 2013 for its wireless version of the product, the Nonin Bluetooth® Smart Model 3230 finger pulse oximeter.
For more information about Nonin's Model 3231 and 3230 finger pulse oximeters for eHealth/OEM applications, visit nonin.com/ehealth.
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.