A laser-based pulse oximeter demonstrated superior accuracy over LED models in SpO2 measurements across skin tones in a study by the UCSF Hypoxia Lab.


RT’s Three Key Takeaways:

  1. Superior Accuracy: A study conducted by the UCSF Hypoxia Lab compared Zynex Inc’s NiCO laser-based pulse oximeter to conventional LED pulse oximeters, finding that the laser-based device demonstrated consistent SpO2 accuracy across skin tones.
  2. Controlled Study: The study included nine darkly pigmented and nine lightly pigmented participants and tested four laser and two LED devices.
  3. Potential Impact: Findings highlight the potential of laser-based oximetry to address inaccuracies in oxygen level measurements, which have been linked to disparities in clinical care.

Medtech company Zynex Inc announced highlights from a recent study comparing its NiCO laser pulse oximeter to conventional LED pulse oximeters for the effects of skin pigmentation on SpO2 measurements conducted by the University of California, San Francisco (UCSF) Hypoxia Lab.

Zynex says its NiCO pulse oximeter utilizes highly precise laser technology to measure blood oxygenation levels directly, as opposed to current pulse oximeter products, which only estimate oxygenation levels using an LED-based technology. LED pulse oximeters have been shown to mismeasure oxygen levels in several populations, most prominently in individuals with darker skin pigmentation.

A poster presentation for the study was recently accepted and presented at the ANESTHESIOLOGY 2024 event hosted by the American Society of Anesthesiologists that took place Oct 18-22 in Philadelphia. The presentation titled, “Laser-Based Pulse Oximetry Eliminates Effects of Skin Pigmentation on SpO2 Measurements,” included results from a study conducted under the supervision of Philip Bickler, MD, PhD, at the UCSF Hypoxia Lab.

Nine darkly pigmented and nine lightly pigmented participants were recruited for this controlled desaturation study. Four NiCO pulse oximeters and two different commercially available LED-based pulse oximeters were used on each participant. Conclusions from the study showed the NiCO pulse oximeter did not demonstrate a bias for dark-pigmented participants compared to lightly pigmented participants. By comparison, conventional LED-based pulse oximeters in the present study read falsely higher on darkly pigmented participants, specifically at lower oxygen saturation levels.

[RELATED: FDA Panel Proposes Solutions to Eliminate Racial Bias in Pulse Oximeters]

“The findings reconfirm the results at a recent study at Duke University that our laser-based pulse oximeter is accurate across all pigmentation levels and is expected to significantly reduce racial disparity in clinical decision-making, such as the need for mechanical ventilation or how much supplemental oxygen to give a patient,” says Donald Gregg, president of Zynex Monitoring Solutions, in a release. “A 2022 study led by Harvard Medical School researchers at Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center, published in JAMA Internal Medicine, concluded that these inaccuracies were associated with disparities in care. The researchers found that, compared to White patients, Black, Hispanic, and Asian patients treated in intensive care units had greater discrepancies between blood saturation levels detected using pulse oximeters versus levels detected in blood samples and received less supplemental oxygen than White patients.

“We remain confident that the clinical value of NiCO’s unparalleled precision, accuracy, and safety provides a game-changing solution to racial disparity as we prepare our application for FDA clearance. We look forward to additional milestones and announcements for NiCO pulse oximetry in the weeks to come.”

Photo caption: NiCO pulse oximeter

Photo credit: Zynex Inc