BioIntelliSense, a continuous health monitoring and clinical intelligence company, has launched a patented, U.S. FDA-cleared, pulse oximetry sensor chipset and integrated processing technology aimed at improving the technology’s sensitivity to skin-color.

The new technology accurately measures blood oxygen levels across the full range of light to very dark skin pigmentations, as well as during movement and activity.

These capabilities represent a significant advancement in the field of oximetry which has historically been challenged by reduced accuracy during activity and in people with darker skin.1,2,3,4   BioIntelliSense’s pulse oximetry (SpO2) technology enables SpO2 monitoring anywhere, anytime, whether in clinical settings, at home, or beyond.

“Addressing these foundational skin pigmentation and motion challenges in the measurement of blood oxygen levels is transformative for the pulse oximetry category and allows for the democratization of this advanced technology across consumer and medical grade devices,” says James Mault, MD, founder and CEO of BioIntelliSense. “This is a significant milestone in providing clinically accurate SpO2 measurements across diverse patient populations which may contribute to improving healthcare equity.”  

BioIntelliSense’s Patented Oximetry Technology

The BioIntelliSense sensor and processing solution is a patented technology, which received FDA 510(k) clearance as the SpO2 technology component in a finger-based monitor in 2021.5 Unlike traditional red and infrared LED architectures, this technology additionally employs a white light emitter, combined with a novel spectral sensor.

The sensor’s oximetry signal processing is designed with an extended dynamic range, maximizing the optical front-end performance, even with very small modulations due to darker skin pigmentation. BioIntelliSense’s solution also continuously adjusts each emitter intensity of the perfused tissue in real time, compensating for higher absorption levels in darker skin tones by increasing tissue illumination.

In multiple clinical hypoxia studies, with and without motion protocols, the BioIntelliSense SpO2 solution
has demonstrated consistent accuracy, exceeding ISO standard 80601-2-61:20171 for darkest skin tones – on par with light skin tones – including at low oxygen saturation ranges.

This patented SpO2 chipset technology, integrated processing and reference design capability uniquely positions BioIntelliSense to enable the next generation of medical and consumer wearable devices that overcome historical challenges in accurate pulse oximetry measurement.

References:

  1. US Food & Drug Administration. Pulse oximeter accuracy and limitations: FDA safety communication. Accessed October 28, 2022. https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication
  2. Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial bias in pulse oximetry measurement. N Engl J Med. 2020;383(25):2477-2478.
  3. Keller MD, Harrison-Smith B. Skin colour affects the accuracy of medical oxygen sensors. Nature. 2022; 610: 449-451.
  4. Torp KD,  Modi P, Simon LV. Pulse oximetry. In: StatPearls. Treasure Island, Florida: StatPearls Publishing; 2022. Accessed October 28, 2022. https://www.ncbi.nlm.nih.gov/books/NBK470348/
  5. FDA clearance K200160, cleared on 02/15/2021.