Masimo’s MightySat Rx Fingertip Pulse Oximeter clears the FDA

MightySat Rx

Masimo has received FDA 510(k) clearance for MightySat Rx, its fingertip pulse oximeter that incorporates Masimo SET Measure-through Motion and Low Perfusion technology.

Said device comes with the same Masimo SET technology that is used in hospitals throughout the world and is present in all Masimo bedside devices as well as many leading multi-parameter monitors. The MightySat noninvasively measures arterial oxygen saturation (SpO2) and pulse rate (PR), in addition to perfusion index (PI) and optional pleth variability index (PVI). The Masimo SET technology enables accurate SpO2 and pulse rate measurements during motion and low perfusion.

The device is available in three versions: MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI.“We are excited to provide clinicians the same accuracy provided by our other monitors in a fingertip pulse oximeter,” said Joe Kiani, Founder and CEO of Masimo. “The MightySat Rx is an impressive device in a very compact form factor that provides clinicians easy access to patient data.”

MightySat Rx is designed to comfortably grip a patient’s finger using a flexible, conforming silicon pad. An OLED display presents information clearly, while a touchpad allows for customization. MightySat Rx is designed to be both rugged and lightweight.

The device is available in three versions: MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI. The versions with Bluetooth can connect with iOS and Android mobile devices to display, trend, and communicate the measurements made on MightySat.