Health tech company Royal Philips announced it has received FDA 510(k) clearance of its next-generation reusable Philips SpO₂ clip sensor, which it said will provide clinicians with trusted oxygen saturation measurements to support confident patient care.

Internal optical refinements have been integrated to enhance the sensor to further improve signal quality and measurement consistency, supporting reliable SpO₂ measurements across diverse patient populations and clinical conditions, the company said. 

In desaturation studies, the reusable clip sensor achieved an accuracy root mean square (ARMS) value of 1.6%, which is nearly twice as accurate as the 3% level recommended by ISO and recognized by the FDA, Philips said. The sensor also demonstrated consistent performance across a broad range of skin tones, with accuracy varying by less than 0.5% between the light and dark skin pigmentation groups evaluated within an SaO₂ range of 85-100%.

The company said the results reflect a rigorous approach to sensor development and validation, and that the company’s SpO₂ sensor portfolio consistently meets 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.”

Pulse oximetry is one of the most widely used monitoring technologies in healthcare, providing clinicians with critical information to assess a patient’s oxygenation status. Because signal quality can be influenced by a range of physiological, clinical and technical factors, Philips takes a thorough approach to developing and evaluating its sensor technologies, combining continuous innovation with rigorous testing designed to support reliable performance in real-world, diverse care environments, the company said.

The FDA-cleared reusable clip sensor is backed by Philips’ comprehensive pulse oximetry validation program, which evaluates performance across diverse patient populations — including varying skin tones — and a broad range of physiological and clinical conditions. Philips’ validation practices align with evolving FDA recommendations and applicable international standards, including those established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Philips said it continues to collaborate with clinicians, researchers, regulators and standards organizations to strengthen the science behind pulse oximetry and support the continued evolution of validation practices. Through ongoing investment in research, innovation and clinical evidence, Philips aims to continue helping advance pulse oximetry that clinicians can trust to perform consistently across diverse skin tones and patient physiological conditions.

The FDA-cleared reusable Philips SpO₂ clip sensor will become available in select markets across the globe later this year.