MightySat Medical : Masimo introduces first FDA-cleared OTC medical fingertip pulse oximeter

Masimo (NASDAQ: MASI) has made an advancement in consumer health technology with the announcement of US Food and Drug Administration (FDA) clearance for MightySat Medical. This marks a significant milestone as MightySat Medical becomes the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) directly to consumers without the need for a prescription. This development stands out in the health and wellness sector, offering a reliable, medical-grade pulse oximetry solution to the public, unlike many other pulse oximeters currently available at drug stores and online, which lack FDA clearance and have been reported to provide inaccurate measurements.

FDA Clearance Sets New Standards for Pulse Oximetry

The MightySat Medical Pulse Oximeter, powered by Masimo SET pulse oximetry technology, brings hospital-grade monitoring to the fingertips of consumers. This technology, trusted by hospitals and clinics globally to monitor over 200 million patients annually, is renowned for its accuracy across different skin tones, including both light- and dark-skinned individuals. Starting today, consumers can purchase the MightySat Medical Pulse Oximeter directly from masimo.com, with availability soon to extend to retail and drug stores nationwide.

Revolutionizing Home Health Monitoring: Masimo’s MightySat Medical Gets FDA Nod. Image courtesy of Business Wire

A Leap Forward in Home Health Monitoring

Joe Kiani, Founder and CEO of Masimo, emphasized the significance of this clearance, highlighting the confusion and misinformation surrounding pulse oximetry products available to consumers. The FDA’s clearance of MightySat Medical aims to eliminate this confusion, offering a trusted, accurate, and reliable option for home health monitoring. This move is particularly crucial for consumers with diagnosed breathing problems or lung diseases, such as asthma, COPD, lung cancer, and COVID-19, who rely on accurate assessments of their arterial blood oxygen saturation.

 Ensuring Accuracy and Reliability in Health Monitoring

The FDA’s 2021 safety communication underscored the limitations of non-medical pulse oximeters, including challenges in measuring accurately during motion, low perfusion, and on darker skin pigmentation. MightySat Medical addresses these concerns by providing a device whose accuracy and reliability have been validated and cleared by the FDA for medical use. This device is intended for spot-checking functional oxygen saturation (SpO2) and pulse rate (PR) in individuals 18 years and older, under no motion conditions, making it an essential tool for health monitoring at home.

Expert Opinions on the Importance of Accurate Pulse Oximetry

Peter Pronovost, MD, PhD, Chief Quality and Clinical Transformation Officer at University Hospitals, Cleveland, highlighted the growing trend of care moving to the patient’s home. He noted the critical need for accurate pulse oximetry data to guide patients on when to seek care. The clearance of MightySat Medical by the FDA ensures that patients and healthcare providers can rely on accurate measurements for effective home health monitoring.