Masimo announced the full market release outside the U.S. of the Pronto® Pulse CO-Oximeter® with Next Generation SpHb® Spot Check technology.
Next Generation Pronto features rainbow SET™ technology, for noninvasive spot checking of total hemoglobin (SpHb), oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).
In addition to the Next Generation SpHb technology, Masimo has also released the rainbow® DCI®-mini reusable sensor to accompany the Pronto. The DCI-mini is a universal sensor usable on patients greater than 3 kg, making Pronto an even more versatile solution.
The Next Generation SpHb technology in Pronto offers motion tolerance and a 40% reduction in time to display SpHb results. Field accuracy has been improved in the range of 6 to 11 g/dL, and is comparable to certain portable invasive point of care devices.
"This is a significant enhancement to the noninvasive measurement we introduced 7 years ago," stated Joe Kiani, Founder and CEO of Masimo.
"Since then, all of the clinical outcome studies we’re aware of on our continuous SpHb technology have been positive,1-3 which is something that couldn’t be said for standard pulse oximetry before the introduction of Masimo SET SpO2. We will continue to improve SpHb until it has the same measure-through motion and low perfusion performance as our SET SpO2 technology."
An upgrade program will be available for qualified existing Pronto customers. Pronto with Next Generation SpHb and the DCI-mini reusable sensor have not received FDA 510(k) clearance and are not currently available for sale in the United States.