Philips Wins FDA Nod for Next-Gen, Reusable SpO₂ Clip Sensor

Philips reported that it’s earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation reusable SpO₂ clip sensor. The company aims to provide trusted oxygen saturation measurements to support confident care.

The new sensor features internal optical refinements to improve signal quality and measurement consistency. The reusable clip sensor showed an Accuracy Root Mean Square (ARMS) value of 1.6% in desaturation studies—almost twice as accurate as the 3% level recommended by ISO and recognized by the FDA.

The sensor also demonstrated consistence performance for a broad range of skin tones, with accuracy varying less than 0.5% between the light and dark skin pigmentation groups assessed with an SaO₂ range of 85-100%.

The FDA-cleared sensor is supported by Philips’ comprehensive pulse oximetry validation program, which evaluates performance across diverse patient populations and a broad range of physiological and clinical conditions. Philips said its validation practices align with changing FDA recommendations and applicable international standards, including those from the ISO and IEC.

The reusable SpO₂ clip sensor will become available in select markets around the world later this year.

“Providing clinicians with reliable data to deliver better care to more people is at the heart of everything we do,” said Sachin Chaudhari, Category Leader, Clinical Measurements and Specialty Monitoring at Philips. “This FDA clearance reflects our ongoing investment in advancing sensor technology and rigorous validation practices, and we’ll continue applying these innovations across our pulse oximetry portfolio so clinicians can make care decisions with even greater confidence.”