Medtronic Wins FDA Nod for Nellcor Pulse Oximetry System with Intelligent Processor

Medtronic has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its Nellcor pulse oximetry system with Nell-EQ intelligent processor.

The Nell-EQ intelligent processor is a new pulse oximetry processing technology engineered to support more consistent, reliable oxygen saturation and pulse rate monitoring across diverse patient populations, skin tones, and clinical care settings.

The regulatory milestone follows the company’s positive verification study results for the Nellcor system with the intelligent processor. The tech was also previously awarded FDA Safer Technologies Program (STeP) designation.

Clinical studies for Nell-EQ included participants across the full range of skin tones. It uses advanced signal processing methods with patient-specific and sensor-specific signal characteristics to support more consistent and reliable interpretation of optical signals into SpO₂ values. In addition to SpO₂ and pulse rate, the platform supports parameters such as Perfusion Index (PI) and Heart Rate Variability (HRV).

Nellcor pulse oximetry with the Nell-EQ intelligent processor will become available for global sale in the coming months, and Medtronic said it plans to support the release with clinician education and training resources.

“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,” said Kate Benedict, president of Medtronic’s Acute Care & Monitoring business. “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.”

Last week, the company announced strategic investments in two privately held companies developing intracardiac echocardiography (ICE) catheter technologies.