Medtronic’s next-generation Nellcor pulse oximetry technology has been accepted into the FDA’s Safer Technologies Program (STeP), a designation aimed at accelerating safer medical device development.
The new Nellcor system is designed to enhance oxygen saturation accuracy by integrating patient- and sensor-specific data, addressing disparities in readings for patients with darker skin pigmentation. This move responds to ongoing concerns about unrecognized hypoxemia linked to melanin’s impact on light absorption.
Accepted under STeP Eligibility Criterion 2a, the device is expected to improve benefit-risk profiles and reduce serious adverse events. The designation signals regulatory support for Medtronic’s efforts to improve equity and safety in clinical monitoring.
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