The Growing Importance of Precision in Oxygen Monitoring   From hospital wards to fitness wearables, pulse oximeters  have become indispensable tools for noninvasively measuring blood oxygen saturation (SpO₂). Yet the accuracy of these devices, particularly across diverse skin tones and environmental conditions, has come under scrutiny in recent years.  As regulatory bodies and clinical researchers call for more inclusive and transparent validation, the need for a specialized

Introduction: A New Standard on the Horizon   On January 6, 2025 , the FDA released a draft guidance  titled Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations . This draft guidance updates and expands upon earlier 510(k) and performance expectations for pulse oximeters, placing renewed emphasis on accuracy across skin pigmentation  and non-disparate performance .   Crucially, the draft does