BioIntelliSense, Inc. a continuous health monitoring and clinical intelligence company, announced the launch of its patented, FDA-cleared pulse oximetery (SpO2) sensor chipset and integrated processing technology that 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. BioIntelliSense’s pulse oximetry (SpO2) technology enables SpO2 monitoring anywhere, anytime, whether in clinical settings, at home, or beyond.
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. 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 solutionhas 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.
BioIntelliSense is actively collaborating with the Medtronic Patient Monitoring business. As recently announced, BioIntelliSense entered into an exclusive strategic partnership with Medtronic for the U.S. hospital distribution rights of the BioButton® multi-parameter wearable for continuous, connected monitoring.
“By leveraging our extensive reach and commercial channels, the Medtronic Patient Monitoring business is excited to work together with our partners at BioIntelliSense to expand access to meaningful technologies to patients anytime, anywhere,” said Frank Chan, Ph.D., president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic.
