Nonin Medical Secures FDA Clearance for Fingertip Pulse Oximeter

PLYMOUTH, Minnesota—Nonin Medical, a manufacturer of wearable and noninvasive medical monitoring devices, announced its first FDA-cleared over-the-counter (OTC) fingertip pulse oximeter, the “TruO2.” The device intends to provide accurate readings on adults of all skin tones, empower patients and health care professionals with accurate measurements and allow for better informed health care decisions.

“Over the past several years, the US market has been flooded with poor quality, health and wellness grade pulse oximeters which are not regulated by the FDA,” said John Hastings, CEO of Nonin Medical. “This creates a confusing and frustrating experience for consumers, including those with conditions like (chronic obstructive pulmonary disease) or asthma, seeking an accurate, equitable and durable solution for home use. The availability of TruO2 OTC now provides all consumers with access to equitable, medical-grade technology that is designed for accuracy across all skin tones. We believe this will significantly enhance the quality and reliability of home-based monitoring, leading to better health outcomes for everyone.”

The company said its dedication to developing accurate pulse oximetry devices across skin pigmentation is a foundation for its product developments. According to multiple independent studies, Nonin Medical’s pulse oximetry technology outperformed low-cost oximeters and other medical-grade oximeters, as well as exceeded FDA requirements. 

With the device’s FDA clearance, the company said it seeks to further its commitment to developing durable and accurate pulse oximetry devices. The TruO2 OTC will be available on Amazon in beginning this month and from other online retailers soon.