Masimo Corp. said the U.S. Food and Drug Administration cleared its Rad-67 device combined with the Spot-check Next Generation SpHb monitoring system and Rainbow DCI sensor to measure the oxygen level in the blood.
Rad-67 is a pulse oximeter, a noninvasive device that measures the fraction of oxygen-carrying hemoglobin to total hemoglobin in the blood. The device also measures methemoglobin, stable oxidized hemoglobin that cannot transfer oxygen to the body's tissues, and a complex of carbon monoxide and hemoglobin called carboxyhemoglobin.
The device also allows for a historical review of the collected data, patient identification and wireless data transfer to electronic medical records. According to the company's March 25 press release, Rad-67 cannot be used for pregnant and pediatric patients as well as those with kidney disease. The device is not a replacement for laboratory blood testing, Masimo said.
The Irvine, Calif.-based healthcare company develops and markets noninvasive monitoring technologies.