Masimo has received FDA 510(k) clearance for the Pronto-7, a new handheld device designed for noninvasive hemoglobin (SpHb) spot-check testing, along with SpO2, pulse rate and perfusion index.
The Pronto-7 features include embedded 802.11 b/g and Bluetooth communication capabilities that make wireless printing and emailing of test results quick and easy and future capabilities enabling wireless transmission to electronic health record (EHR) systems are planned.
Masimo claimed that Pronto-7 is the first device to feature Rainbow 4D designed for fast and accurate spot-check SpHb measurements, along with SpO2 and pulse rate, even in low perfusion conditions.
The palm-sized Pronto-7, advanced over traditional lab testing, with dimensions of just 5.1″ x 2.8″ x 1″ and weight of 10.5 ounces represents a solution for measuring hemoglobin in less than one minute. It puts the power of noninvasive hemoglobin spot-check testing into any clinician’s hands in almost any environment without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests.
Joe Kiani, founder and CEO of Masimo, said: “We are happy that in addition to the CE Marking we now have FDA clearance for Pronto-7, allowing US clinicians and patients to also benefit from the latest technology for noninvasive hemoglobin spot-check testing.”
Anunciacion Andro, a busy primary care physician in Hesperia, California, said: “The ability to get noninvasive hemoglobin spot-check results has been a great benefit to my patients who are happy to not be stuck with a needle.”