Medtronic Secures FDA 510(k) Clearance for Nellcor Pulse Oximetry System with Nell-EQ Smart Processor

The Nellcor pulse oximeter

This new Nell-EQ intelligent processor technology is designed to support more stable and reliable monitoring of blood oxygen saturation (SpO₂) and pulse rate. It is suitable for various patient populations, skin tones, and clinical care settings.

Medtronic stated that its FDA approval was based on positive validation study results released earlier this year. Furthermore, the technology was included in the FDA’s “Safer Technologies Program” (STeP) last year. This collaborative program aims to shorten the time required for research and development and market authorization of eligible medical devices. The FDA launched the STeP program in 2021, modeling it after its Breakthrough Devices Program.

Nellcor’s Nell-EQ system employs advanced signal processing techniques to effectively monitor patients across a wide range of skin tones. By integrating patient- and sensor-specific signal characteristics, it enables more consistent and reliable interpretation of optical signals as SpO₂ values. The platform also supports parameters such as Perfusion Index (PI) and Heart Rate Variability (HRV).

Medtronic plans to globally launch the Nellcor pulse oximetry monitoring system equipped with Nell-EQ technology in the coming months. The company expects to support the rollout by providing educational and training resources for clinicians.

Kate Benedict, President of Medtronic’s Acute Care and Monitoring business, stated:

“With this FDA approval, our innovative Nell-EQ system expands Medtronic’s pulse oximetry monitoring portfolio. Its intelligent processing platform is designed to enhance clinical confidence and facilitate more comprehensive patient care. Our Nellcor pulse oximetry monitoring systems, equipped with the Nell-EQ intelligent processor, continue our long-standing commitment to delivering reliable monitoring performance for diverse patient populations across various healthcare settings.”

Dr. Jeb Denny, Chief Medical Officer of Medtronic’s Acute Care and Monitoring business, stated:

“With the Nellcor pulse oximetry monitoring system equipped with the Nell-EQ intelligent processor, Medtronic continues to lead industry development, advance pulse oximetry monitoring technology, and help clinicians provide confident and equitable medical care to every patient in various healthcare settings. Our sustained leadership reflects our firm commitment to inclusive innovation and to providing clinicians with trustworthy technologies that support all patients in receiving high-quality medical care throughout their healthcare journey.”