Philips receives FDA clearance for SpO2 sensor

Philips announced on July 21, 2026 that the U.S. United States — Food and Drug Administration (FDA) granted 510(k) clearance for its next-generation reusable Philips SpO2 clip sensor. The sensor incorporates internal optical refinements to improve signal quality and measurement consistency, achieving an Accuracy Root Mean Square (ARMS) value of 1.6%, nearly twice as accurate as the 3% level recommended by ISO. Performance was consistent across a broad range of skin tones, with accuracy varying by less than 0.5% between light and dark skin pigmentation groups. The sensor will become available in select markets globally later this year.