The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its Nellcor pulse oximetry system with the Nell-EQ intelligent processor. The technology is designed to support more consistent and reliable oxygen saturation and pulse rate monitoring across diverse patient populations, skin tones, and clinical care settings.
The regulatory clearance follows the announcement of positive verification study results for the system earlier this year. The technology was also previously granted FDA Safer Technologies Program designation for medical devices expected to improve the safety of currently available equipment.
“With this FDA clearance, our innovative Nell-EQ system expands the Medtronic pulse oximetry portfolio with an intelligent processing platform designed to support both clinical confidence and more inclusive care,” says Kate Benedict, president of the Medtronic acute care and monitoring business, in a release. “Our Nellcor pulse oximetry system with Nell-EQ intelligent processor builds on our longstanding commitment to delivering reliable monitoring performance for diverse patient populations across care environments.”
Addressing Performance Variability
Pulse oximetry plays a critical role in clinical assessment, yet performance has historically varied depending on clinical conditions, patient physiology, and skin tone, which can impact signal reliability, the company states in a press release. The clearance comes as the International Organization for Standardization published new standards, ISO 80601-2-61:2026, during a period of increased regulatory focus on evaluating pulse oximeter performance across defined skin tone groups.
Clinical studies for the system included participants across a full range of skin tones. The technology uses signal processing methods that incorporate patient-specific and sensor-specific characteristics to support the interpretation of optical signals into oxygen saturation values. In addition to oxygen saturation and pulse rate, the platform supports parameters such as perfusion index and heart rate variability.
“With our Nellcor pulse oximetry system with Nell-EQ intelligent processor, Medtronic continues to lead the industry in advancing pulse oximetry technology that helps clinicians deliver confident, equitable care for every patient, in every care setting,” says Jeb Denny, MD, chief medical officer of the Medtronic acute care and monitoring business, in a release.
Global Availability and Education
The pulse oximetry technology will be available for sale globally in the coming months. Medtronic plans to support the rollout with clinician education and training resources.
The company currently provides educational resources through the Medtronic Academy regarding how pulse oximeters work and methods for obtaining accurate readings from existing devices. Medtronic remains part of the Safer Technologies Program and continues to invest in professional education and innovation related to equitable patient monitoring.
The company notes that acute care and monitoring products should not be used as the sole basis for diagnosis or therapy, and oxygen saturation accuracy can be affected by environmental, equipment, and patient physiologic conditions.
