BioIntelliSense launches dark skin-friendly oximeter

The Food and Drug Administration (FDA) is conducting a meeting session to evaluate and discuss recent studies indicating that pulse oximeters are less effective on individuals with darker skin and BioIntelliSense is a medical technology company looking to offer a solution. 

BioIntelliSense is focusing on health monitoring and clinical intelligence for Remote Patient Monitoring. 

The company introduced a new pulse oximetry sensor chipset a few hours before the FDA’s meeting to evaluate current oximeters for dark skin. 

Most pulse oximeters transmit red and infrared light through a patient’s skin on their finger, then analyze how the patient’s blood changes that light to calculate the percentage of oxygen in their red blood cells. The BioIntelliSense version, on the other hand, includes a white light and spectral sensor, allowing it to automatically adjust to varying skin tones.

The company claimed that its system continuously adjusts the quantity of light output based on skin absorption to guarantee that all blood cells are lighted equally. Studies show that darker skin tones have been observed to absorb light before it can reach the tissue and thus, current oximeters may not provide accurate readings. 

There have been various testing phases of the oximetry chipset conducted by the company. It was found that the chipsets can detect hypoxia which is when blood oxygen drops to life-threatening low levels, with similar accuracy across all skin tones. Although it was tested on a variety of oxygen levels to check different possible aspects

In addition, unlike standard pulse oximeters, which require the user to stay still while a measurement is taken, the spectral sensor allows the system to continue working even when the user is moving.

The CEO of BioIntelliSense James Mault stated that in the first quarter of 2021, the FDA approved the technology as part of Zoe Medical’s hospital patient monitoring system. This will be integrated with the hospital monitoring systems to be used across consumers and medical grade sets.

BioIntelliSense has made separate deals with Lifesignals and Biostrap devices to include its pulse chipset technology into their medical grade sets followed by the company’s own BioButton which is ready to be used across hospitals in the U.S. via Medtronic. 

In recent years, a growing body of research has revealed differences in pulse oximeter accuracy between patients with light and dark skin. A recent study indicated that typical pulse oximeters were substantially more likely to overlook cases of hypoxia in Asian, Black, and Hispanic COVID-19 patients than in white patients. As a result of the error, those patients had a significant delay in receiving potentially life-saving COVID medicines.

The FDA’s medical devices advisory committee’s anesthesiology and respiratory therapy devices panel will meet in November. Its goal is to discuss the devices’ inherent racial prejudices and provide a set of potential regulatory suggestions to help device-makers create more accurate products.