Key Highlights
- Masimo announces FDA clearance for MightySat® Medical, the first OTC fingertip pulse oximeter for direct consumer purchase.
- Utilizes Masimo SET® technology, ensuring accurate and reliable oxygen saturation and pulse rate measurements for all skin colors and low perfusion patients.
- Available for purchase on masimo.com, with retail availability coming soon, enhancing accessibility for consumers and healthcare providers.
Source: Business Wire
Notable Quotes
- “This clearance of MightySat Medical for consumers eliminates the confusion, placing an FDA-cleared, accurate, reliable, and revolutionary SET® pulse oximeter, with technology that hospitals have been using for more than 25 years, directly into their hands.” – Joe Kiani, Founder and CEO at Masimo
- “More and more care is moving to the patient’s home…Yet to be useful, their pulse oximetry data must be accurate and the accuracy of these devices varies widely. Doctors and nurses rely on Masimo technology in the hospital.” – Peter Pronovost, MD, PhD, Chief Quality and Clinical Transformation Officer at University Hospitals, Cleveland
SoHC's Take
Masimo’s MightySat® Medical represents a significant advancement in the realm of home health monitoring, setting a new standard for accuracy and reliability in consumer-available pulse oximeters. This FDA clearance not only offers peace of mind to consumers seeking dependable home health monitoring solutions but also marks a pivotal moment in the democratization of medical-grade technology. By making Masimo SET® technology, a cornerstone in clinical settings for over two decades, accessible to the general public, Masimo addresses a critical gap in consumer health devices. The implications for patient care are profound, particularly for individuals with respiratory conditions who require precise and consistent monitoring. MightySat® Medical’s availability paves the way for enhanced patient engagement in their own health management, potentially reducing emergency visits and hospitalizations through early detection and intervention. This move by Masimo underscores the growing importance of reliable home health technology in today’s healthcare ecosystem, emphasizing the need for medical devices that meet rigorous standards for accuracy and reliability.
