The FDA has authorized 510(k) clearance for Masimo Corp’s MightySat Rx, a fingertip pulse oximeter that incorporates Masimo SET Measure-through Motion and Low Perfusion technology, according to a company announcement.
The MightySat, which can be paired with iOS or Android devices to report data, is designed to comfortably grip a patient’s finger using a flexible, conforming silicon pad, Masimo says. An OLED display presents information clearly and a touchpad allows for customization.
The device noninvasively measures SpO2 and pulse rate (PR), in addition to perfusion index (PI) and optional pleth variability index (PVI), using the same Masimo SET technology found in all Masimo bedside devices and in many leading multi-parameter monitors.
“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, NY. “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.”
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 allow iOS and Android mobile devices to display, trend, and communicate the measurements made on MightySat, using the free, downloadable Masimo Professional Health app.
“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.”