The medtech giant designed its new Nell-EQ intelligent processor technology to support more consistent and reliable oxygen saturation (SpO₂) and pulse rate monitoring. It works across diverse patient populations, skin tones and clinical care settings.
Medtronic said its FDA clearance follows positive verification study results reported earlier this year. Additionally, the technology was granted acceptance into the FDA’s Safer Technologies Program (STeP) last year. The collaborative program helps reduce the time needed to develop and earn marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program.
Nellcor with Nell-EQ uses advanced signal processing methods to effectively monitor patients across the full range of skin tones. It incorporates patient-specific and sensor-specific signal characteristics to support more consistent and reliable interpretation of optical signals into SpO₂ values. The platform also supports parameters like perfusion index (PI) and heart rate variability (HRV).
Medtronic plans to make Nellcor pulse oximetry technology with Nell-EQ available for sale globally in the coming months. It expects to support the rollout with clinician education and training resources.
Commentary from Medtronic officials
Kate Benedict, president of the Medtronic Acute Care & Monitoring business, said:
“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. 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.”
Dr. Jeb Denny, chief medical officer of the Medtronic Acute Care & Monitoring business, said:
“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. Our continued leadership reflects a deep commitment to inclusive innovation and equipping clinicians with trusted technology that supports high-quality care for all patients across the continuum of care.”
