FDA clears Masimo’s forehead sensor for pulse oximetry monitoring

By Heather Mack
02:55 pm

Irvine, California-based Masimo Technologies, which makes non-invasive patient monitoring devices and sensors, has received FDA 510(k) clearance for its forehead sensor.

The adhesive TFA-1 Forehead Sensor was developed to allow clinicians to monitor patients using pulse oximetry technology from an alternative site instead of a finger. Forehead sensors are easier to access during surgery and resuscitation, and the single-use intention of the TFA-1 negates the necessity for cleaning, storage and inter-department transport that is required of reusable sensors.
Beyond ease of use, forehead sensors are also appealing as they may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes.

Masimo’s technology, SET, is used on over 100 million patients per year at many of the country’s top 10 hospitals. SET includes measurement of oxygen saturation, pulse rate, perfusion index, and a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.


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