IRVINE, California — (BUSINESS WIRE) — Masimo (NASDAQ: MASI) heeft vandaag bekendgemaakt dat er een FDA 510(k) goedkeuring is voor MightySat Rx, een pulse-oxymeter waarin de Masimo SET® Measure-through Motion en Low Perfusion™ technologie samen zitten.
MightySat Rx kent dezelfde Masimo SET® technologie die wordt gebruikt in toonaangevende ziekenhuizen wereldwijd en in alle bedapparaten van Masimo, evenals in vele toonaangevende multiparameter monitoren. De non-invasieve MightySat meet het zuurstofgehalte in aderen (SpO2) en de hartslag, in aanvulling op de perfusie index (PI) en de optionele pleth variability index (PVI®). Masimo SET® technologie maakt nauwkeurige SpO2- en hartslagmetingen mogelijk tijdens beweging en lage doorbloeding.
Masimo Announces FDA 510(k) Clearance for MightySat™ Rx Fingertip Pulse Oximeter
IRVINE, Calif.–(BUSINESS WIRE)– Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for MightySat Rx, a fingertip pulse oximeter that incorporates Masimo SET® Measure-through Motion and Low Perfusion™ technology.
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MightySat Rx features the same Masimo SET® technology that is used in leading hospitals worldwide and is present in all Masimo bedside devices and in many leading multi-parameter monitors. The MightySat noninvasively measures arterial oxygen saturation (SpO2) and pulse rate (PR), in addition to perfusion index (PI) and optional pleth variability index (PVI®). Masimo SET® technology enables accurate SpO2 and pulse rate measurements during motion and low perfusion.
“We use Masimo SET® throughout our hospital, and now MightySat Rx allows me to use Masimo SET® technology in a fingertip pulse oximeter – without compromising on performance,” said Jon Carlson, RT, RRT-NPS, Director of Respiratory Care Services at Mercy Hospital of Buffalo, New York. “Its portability, durability, and convenient, small size are key. By pairing the device with my iPhone, I can easily view my patients’ SpO2 and pulse rate trends.”
MightySat Rx is designed to comfortably grip a patient’s finger using a flexible, conforming silicon pad. An OLED display presents information clearly and a touchpad allows for customization. MightySat Rx is designed to be both rugged and lightweight.
“We are excited to provide clinicians the same accuracy provided by our other monitors in a fingertip pulse oximeter,” said Joe Kiani, Founder and CEO of Masimo. “The MightySat Rx is an impressive device in a very compact form factor that provides clinicians easy access to patient data.”
MightySat Rx is available in three versions: MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI. The versions with Bluetooth allow iOS and Android™ mobile devices to display, trend, and communicate the measurements made on MightySat, using the free, downloadable Masimo Professional Health app.
For more information on MightySat Rx, go to www.masimo.com/pulseOximeter/mightysatRx.htm.
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Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo’s unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Irene Paigah, 858-859-7001