Melanin Bias Reducing Pulse Oximeter and Patient Monitor Systems

During COVID-19 (due to the extreme increase in hospitalizations of the overall population) physicians began noticing that current pulse oximeters on the market had an inherent bias. This bias caused device limitations, often causing pulse oximeters to display falsely high blood oxygen saturation readings on individuals with darker skin tones (higher melanin concentrations). These patients were often being sent home without treatment, when in reality they should have been admitted for lifesaving oxygen therapy.

In the spring of 2021,  invitro studies and research was performed at PSU Labs, which led to JMad Creations, LLC. (JMC)'s re-design of pulse oximeters to reduce the melanin bias found in meters currently on the market. At JMC, further design and engineering was performed, and the process of commercializing the pulse oximeter began. JMC pushed the innovation further by developing plans to integrate the pulse oximeter into a fully wireless patient monitoring system, including completely wireless heart telemetry monitoring (ECG), patient call systems, and patient location and fall monitoring systems. The pulse oximeter demo prototype utilizes a finger clip design for easy integration into existing medical personnel workflows. However, the pulse oximeter has also been designed to conform to all patients including infants, amputees, and those with poor circulation by using a unique and innovative flexible ring design with the same new melanin bias reducing sensor technology as the finger clip design. The system can also be easily integrated into smart device, military devices, first responder devices,  and other technology for at home monitoring systems. 

More recently, research performed at the University of Michigan, MIT, and other universities and medical facilities have supported JMC's research and concluded that current pulse oximeters cause up to a three times higher frequency of hidden hypoxemia and a higher disparity of care for persons with higher concentrations of melanin in the skin (those with darker skin tones). JMC’s device was published (without request) in the BioWorld (a Clarivate News Service) Current Patent Gazette February 2023 edition as being one of the most innovative medical technology development patents with a pre-issuance publication in the world that month.

JMC's pulse oximeter took home the Grand Prize, PSU LaunchBox Boost Award, and at least 6 months of mentorship at the Lehigh Venture Lab (extended to project acquisition) at the Factory LLC Start Up Lehigh Valley (SULV) 2023 Lehigh University Sponsored Pitch Competition (see video below).

On January 9th, 2024, the USPTO issued, to JMC, patents for both a method for reducing melanin bias in pulse oximeters and an article and system patent for melanin bias reducing pulse oximeter and patient monitoring systems and devices. These patents have a priority date of August 2021, which solidifies their inception before many others in the industry began work on new melanin bias reducing technology in pulse oximetry. JMC owner, Jonathan Maderic, is the first named inventor on these patents, and these patents are assigned to and owned by JMC. 

JMC's advances and patents provide a solution to this melanin bias issue at its hardware root via proprietary optics complemented with custom software. Additional patents in the US and across the world in foreign countries are well underway. As this innovation progresses, JMC will provide additional updates.

Patented (US11864923B2, US11864921B2). Additional US and International Patents Pending.