IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for MightySat Rx, a fingertip pulse oximeter that incorMightySat Rx features the same Masimo SET® technology that is used in leading hospitals worldwide and is present in all Masimo bedside devices and in 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®). Masimo SET® technology enables accurate SpO2 and pulse rate measurements during motion and low perfusion.

“We use Masimo SET® throughout our hospital, and now MightySat Rx allows me to use Masimo SET® technology in a fingertip pulse oximeter - without compromising on performance,” said Jon Carlson, RT, RRT-NPS, Director of Respiratory Care Services at Mercy Hospital of Buffalo, New York. “Its portability, durability, and convenient, small size are key. By pairing the device with my iPhone, I can easily view my patients’ SpO2 and pulse rate trends.”

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

“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 available in three versions: MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI. The versions with Bluetooth allow iOS and Android™ mobile devices to display, trend, and communicate the measurements made on MightySat, using the free, downloadable Masimo Professional Health app. porates Masimo SET® Measure-through Motion and Low Perfusion™ technology.