FDA Clears Medtronic's Nellcor Nell-EQ Pulse Oximeter Under New Skin-Tone Equity Standard

The Nell-EQ intelligent processor is the first pulse oximetry system to meet ISO 80601-2-61:2026, a global standard that for the first time requires manufacturers to validate SpO₂ accuracy across defined skin-tone groups.

Medtronic announced on June 8, 2026 that the FDA has granted 510(k) clearance to its Nellcor pulse oximetry system equipped with the Nell-EQ intelligent processor — a redesigned signal-processing engine built to deliver consistent blood-oxygen readings regardless of a patient’s skin pigmentation.

The clearance arrives in the wake of ISO 80601-2-61:2026, a newly published revision to the global pulse oximeter performance standard that, for the first time, requires device makers to demonstrate accuracy across defined skin-tone groups rather than a predominantly light-skinned validation cohort. According to Medtronic, Nell-EQ is the first commercially cleared pulse oximeter to meet that updated standard.

The FDA had previously granted the technology its Safer Technologies Program (STeP) designation — a pathway reserved for devices reasonably expected to meaningfully improve on the safety of currently marketed alternatives, and one that affords closer FDA collaboration during development and review.

The urgency behind both the new standard and the STeP designation traces back to a well-documented clinical problem. Studies conducted during the COVID-19 pandemic found that conventional pulse oximeters overestimate blood-oxygen saturation in patients with darker skin, with SpO₂ readings running 0.6 to 1.5 percentage points higher than measured arterial saturation. That gap translated into false-negative rates for hypoxemia that were up to 35 percentage points worse in darker-skinned patients — delays that likely contributed to higher COVID-19 mortality among Black and Hispanic patients.

Nell-EQ addresses the problem through advanced signal processing that incorporates patient-specific and sensor-specific optical signal characteristics, reducing the distorting influence of melanin on light-absorption measurements.

Clinical validation spanned 146 adult subjects and 319 pediatric cardiac patients across the full spectrum of skin tones. Medtronic reported that accuracy met or exceeded the threshold set in FDA’s draft guidance for diverse-population performance.

The Nellcor platform is one of the most widely deployed pulse oximetry systems in hospital critical care, making the Nell-EQ upgrade potentially significant in scale as well as design.

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