Masimo granted FDA clearance for Pronto-7 noninvasive hemoglobin spot-check testing device

Masimo (Nasdaq: MASI), the inventor of Masimo Rainbow Pulse CO-Oximetry™, Masimo Rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA 510(k) clearance for the Pronto-7™—a new handheld device designed for quick and easy noninvasive hemoglobin (SpHb®) spot-check testing, along with SpO2, pulse rate, and perfusion index, in virtually any environment.

Masimo Founder and CEO, Joe Kiani, stated: "We are happy that in addition to the CE Marking we now have FDA clearance for Pronto-7, allowing U.S. clinicians and patients to also benefit from the latest technology for noninvasive hemoglobin spot-check testing."

Dr. Anunciacion Andro, a busy primary care physician in Hesperia, California, says needle-less, pain-free hemoglobin testing has big patient care benefits: "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."

Dr. Aditya Chopra, a private practice internist in Annapolis, MD, confirmed the value of fast, point-of-care spot-check testing in his practice, saying: "Noninvasive hemoglobin spot-check testing has increased the efficiency of my practice by reducing the time to take blood, send it to the lab, and call patients back with their results."

A low hemoglobin level is called anemia, a pervasive blood disorder that, according to the World Health Organization (WHO), affects 1.6 billion people worldwide and causes one million deaths a year. A top-ten risk factor contributing to the global burden of disease, anemia results in lost cognitive function and productivity that is estimated to cost $50 billion annually in gross domestic product (GDP) losses worldwide. Chronic anemia is characterized by consistently low hemoglobin levels that can be the result of a diet deficiency or illness such as cancer. Acute anemia is a sudden drop in hemoglobin levels that can result from internal or external bleeding due to surgery or trauma.

According to Aryeh Shander, M.D., President-Elect of the Society for the Advancement of Blood Management (SABM) and the Executive Medical Director for The Institute for Patient Blood Management & Bloodless Medicine and Surgery at Englewood Hospital and Medical Center in Englewood, New Jersey, "Noninvasive hemoglobin testing at the point-of-care offers a giant leap forward in our ability to tackle the global burden of anemia. Although it is a common blood disorder, it is grossly under-tested and under-diagnosed. And, if left untreated, anemia has a variety of serious health consequences and complications. The beauty of immediate, noninvasive hemoglobin testing is that it will allow more patients to be assessed, so their physician can determine additional test options and initiate potentially lifesaving treatment."

Hemoglobin is one of the most commonly ordered tests in both hospital and non-hospital settings because it is critical to assessing anemia and blood loss. However, traditional lab testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results. The palm-sized Pronto-7—with dimensions of just 5.1" x 2.8" x 1" and weight of 10.5 ounces— represents a breakthrough 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.

Pronto-7 features 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. It is also the first Masimo 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.

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