Irvine, Calif.-based Masimo Corporation has earned the CE mark for its Mightysat Rx fingertip pulse oximeter for clinical use in the CE countries. The system offers the same Masimo SET (signal extraction technology) Measure-Through Motion and Low Perfusion pulse oximetry technology already in use with other Masimo pulse oximetry devices.

Bluetooth-enabled versions of Mightysat Rx allow clinicians to track and trend up to 12 hours of patient measurements on smart mobile devices, and to share that data via standard CSV (comma separated values) files as well as transfer to Apple’s Health app, the company claims.

Mightysat Rx is designed for accurate, noninvasive spot-checking of oxygen saturation (SpO2) and pulse rate (PR) for adult and pediatric patients even during motion and low perfusion. Mightysat Rx measures and displays Perfusion Index (PI), which reflects the strength of the pulsatile signal. Mightysat can also measure and display Pleth Variability Index (PVI), a measure of the dynamic changes in the PI that occur during one or more complete respiratory cycles. PI is the ratio of blood flow to static blood in peripheral tissue.

“Many clinicians around the world rely on pulse oximetry as the fifth vital sign,” stated Joe Kiani, Founder and CEO of Masimo. “The Mightysat Rx represents a significant milestone. To deliver Masimo SET performance in this low-power form factor took some engineering, given the precision of our technology and SET’s computationally intensive algorithm. We actually dropped the power consumption by nearly two orders of magnitude. But the development effort was worth it, as we expect this technology will empower clinicians and they will no longer have to compromise performance for mobility.”

Masimo makes noninvasive monitoring technologies.