We reported on the introduction of Masimo‘s Pronto 7 back in June 2010. To review, this handheld, noninvasive device provides a spot-check of hemoglobin (SpHb), SpO2, pulse rate, and perfusion index. Since then, Masimo voluntarily recalled the sensors associated with this device due to problems with reliability of data at low ambient temperatures. The company has subsequently redesigned the sensors and re-validated the data with thousands of patients.
With the new sensors validated, Masimo has initiated international availability of Pronto-7 in Europe, Middle East, Africa, South America, and Asia (except for countries requiring clearance, such as Japan). As far as the U.S. is concerned, FDA 510(k) clearance is pending at this time.
Masimo Founder and CEO, Joe Kiani, stated: “We take the integrity of our design and our promises to our customers seriously. We worked through the recall until we had redesigned the sensor for Pronto-7 so that it would perform as intended in the broadest range of likely ambient temperatures. We are delighted to re-introduce the Pronto-7…”
Noninvasive pulse oximetry changed the way anesthesiology was practiced when it was introduced – let’s hope that technologies like this can continue to improve the way we care for our patients going forward.
Product page: Pronto-7 …