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

IRVINE, CA --- Masimo announces 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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