BioIntelliSense, a continuous health monitoring and clinical intelligence company, have launched a patented, FDA-cleared pulse oximeter technology that addresses challenges with skin tone and motion monitoring, faced by traditional pulse oximeter devices. The technology will be integrated into the company’s own wearable device, BioButton.

Why it’s Notable:

• Research has shown that racial bias exists in traditional pulse oximetry measurement. The new technology developed by BioIntelliSense, is able to detect hypoxia with the same level of accuracy for any skin tone. While traditional pulse oximeters emit red and infrared light, this new technology additionally employs a white light emitter, combined with a novel spectral sensor, which allows the device to adapt to different skin pigmentations. The system continuously adjusts the amount of light emitted based on its absorption by the skin, compensating for higher absorption levels in darker skin tones by increasing tissue illumination.

• The advanced technology by BioIntelliSense can also capture oximetry measurements while the patient is moving. With this advancement, oximetry measures captured while in motion can assist with ensuring optimal oxygen delivery to patients during transportation. This advancement enables the technology to be incorporated into wearable devices, potentially expanding accessibility.

Industry Implications:

• Improved health equity: Devices have been shown to regularly overestimate oxygen saturation levels in people with darker skin tones, often leading to undetected hypoxemia. In light of growing evidence, the FDA recently held a meeting to address this disparity in pulse oximeter accuracy between lighter and darker skin tones. The meeting was aimed at developing a set of potential regulatory recommendations to guide device makers in developing more equitable products. BioIntellioSense’s new technology represents a significant advancement in the field of oximetry, addressing this pressing issue and placing the company a step ahead of others in the market space.

• Market expansion: BioIntelliSense’s new technology looks set for expansive market reach, through a number of strategic partnerships. They have a strategic partnership with Medtronic, a global pulse oximetry market leader, for distribution of their wearable device BioButton, which now incorporates the advanced oximetry technology. Leveraging Medtronic’s expansive commercial channels, as well as integrating their technology with LifeSignals and Biostrap wearables, BioIntelliSense have the potential to bring their solution to a large population, expanding patient access to equitable pulse oximetry measurements.