Dive Brief:
- Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says is accurate across a broad range of skin tones.
- The reusable clip sensor has optical refinements to improve signal quality and measurement consistency and support reliable oxygen saturation measurements across diverse patient populations and clinical conditions, the company said in the Tuesday announcement.
- Medtech firms have sought to update their pulse oximetry technology after several studies raised concerns about the devices being less accurate for people with dark skin pigmentation. The Food and Drug Administration issued updated testing recommendations for pulse oximeters in a 2025 draft guidance, but has not finalized it.
Dive Insight:
Philips plans to make the SpO₂ clip sensor available in certain markets around the world later this year. The medtech firm said the device was tested under its pulse oximetry validation program, which evaluates device performance across diverse patient groups and a range of physiological and clinical conditions.
Philips said the new device was tested in desaturation studies, which demonstrated an accuracy root mean square value of 1.6%. The measurement is used to calculate the difference between pulse oximeter readings and actual blood oxygen saturation.
Philips said its results were nearly twice as accurate as the 3% level recommended by the International Organization for Standardization and recognized by the FDA. In particular, the company said the device had consistent performance across a broad range of skin tones, with accuracy varying by less than 0.5% between people with light and dark skin pigmentation.
Disparities in pulse oximeter accuracy have been the focus of discussions by researchers and regulators for the last several years. In 2021, the FDA issued a warning about problems with pulse oximeter accuracy, following a study published in the New England Journal of Medicine showing Black patients were three times more likely than white patients to have hypoxemia that went undetected by the devices. Another study published in JAMA in 2022 found that disparities in pulse oximeter accuracy led to delayed COVID-19 treatment eligibility in Black and Hispanic patients.
The FDA issued draft guidance in early 2025, in the final weeks of the Biden administration, calling for studies of pulse oximeters to have a minimum of 150 people and with more specific guidelines on how to ensure participants include a range of skin tones. The guidance still has not been finalized, and was on the FDA’s “under construction” list for the current fiscal year.
Device companies have sought to bring updated pulse oximeters to market with claims that the new devices don’t have disparities in accuracy across skin tones. Medtronic said last month that it had received FDA clearance for an updated version of its Nellcor pulse oximetry system, saying it performed better than the requirements set out in the FDA’s guidance across the full range of skin tones.
