Royal Philips has received US Food and Drug Administration (FDA) 510(k) clearance for its next-generation reusable Philips SpO₂ clip sensor, designed to deliver more accurate and consistent blood oxygen saturation (SpO₂) measurements across a wide range of patients and clinical settings.
According to the company, the upgraded sensor features internal optical refinements that improve signal quality and measurement consistency, helping clinicians obtain reliable SpO₂ readings in diverse patient populations and varying clinical conditions.
In desaturation studies, the reusable clip sensor achieved an Accuracy Root Mean Square (ARMS) value of 1.6%, outperforming the 3% accuracy threshold recommended by the International Organization for Standardization (ISO) and recognized by the FDA. The device also demonstrated consistent accuracy across different skin tones, with measurement differences of less than 0.5% between light- and dark-pigmented skin groups within an arterial oxygen saturation (SaO₂) range of 85% to 100%.
Philips said these results reflect its rigorous approach to sensor development and validation, with the company’s SpO₂ sensor portfolio consistently meeting applicable regulatory performance expectations.
“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,” he added.
The reusable clip sensor is supported by Philips’ comprehensive pulse oximetry validation programme, which evaluates performance across diverse patient populations—including varying skin tones—and a broad range of physiological and clinical conditions.
The company’s validation methods align with evolving FDA guidance and internationally recognised standards set by ISO and the International Electrotechnical Commission (IEC).
Philips said the FDA-cleared reusable SpO₂ clip sensor will be introduced in select global markets later this year.
