Philips has received US Food and Drug Administration 510(k) clearance for its next-generation reusable adult SpO2 clip sensor.
The device is designed to measure peripheral oxygen saturation and incorporates internal optical refinements intended to improve signal quality and measurement consistency across different patients and clinical conditions.
Pulse oximetry is used across hospitals and other care settings to monitor blood-oxygen saturation. Measurement reliability may be affected by factors including patient movement, perfusion, sensor positioning and physiological differences between patients.
Philips said the enhanced clip sensor achieved an Accuracy Root Mean Square value of 1.6% in controlled desaturation studies. This compares with the 3% performance level recommended under the relevant ISO standard and recognised by the FDA.
The reusable sensor is available in 0.9-metre and three-metre cable configurations and is classified by the FDA as an oximeter.
According to the FDA device database, the sensor was reviewed through the traditional 510(k) pathway and received a substantially equivalent determination.
Philips said the device will be incorporated into its patient-monitoring portfolio to support oxygen-saturation measurement across a range of hospital environments.