Masimo Announces FDA 510(k) Clearance for TFA-1 Single-Patient-Use Forehead Sensor

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ:MASI) announced today FDA 510(k) clearance for the TFA-1™ Single-Patient-Use Adhesive Forehead Sensor. This single-patient-use sensor allows clinicians to monitor patients using Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry from an alternative monitoring site, the forehead, rather than a finger.

Forehead sensors may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes, and were shown in a 2004 study to have faster detection of desaturation and resaturation, as compared to digit sensors.¹ Forehead sensors can also be easily accessed during surgery and resuscitation and on patients with finger deformities or whose fingers are not accessible. As a single-patient-use sensor, TFA-1 avoids the management complexities (cleaning, storage, and inter-department transport) that accompany reusable sensors.

Masimo SET^® includes measurement of oxygen saturation (SpO₂), pulse rate (PR), perfusion index (PI), and PVI^®, a measure of the dynamic changes in PI that occur during the respiratory cycle. Masimo SET^® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Masimo SET^® helps clinicians monitor more than 100 million patients a year² and is used by 8 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.³

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References

1. Redford DT et al. Intraoperative Perfusion Changes at Two Pulse Oximetry Monitoring Sites: The Digit vs. the Nare. Anesth Analg. 2004;98(2S)S-94.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo

Masimo (NASDAQ: MASI) is a 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. Masimo SET^® 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 more recently, Pleth Variability Index (PVI^®) and Oxygen Reserve Index (ORI™), in addition to SpO₂, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements

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 include, among others, statements regarding the potential effectiveness of Masimo TFA-1™ Sensor and SET^® pulse oximetry. 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 Masimo TFA-1 Sensor and SET^® pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide comparable accuracy and unique advantages; 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.