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FDA approves Masimo’s TFA-1 single-patient-use forehead sensor

Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its TFA-1 single-patient-use adhesive forehead sensor.

The sensor enables clinicians to monitor patients from an alternative monitoring site forehead rather than finger by using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry.

Forehead sensors can be easily accessed during surgery and resuscitation, as well as on patients with finger deformities or whose fingers are not accessible.

TFA-1 helps to avoid management complexities such as cleaning, storage, and inter-department transport.

According to the company, the forehead sensors offer oxygen saturation measurements that are less susceptible to peripheral perfusion changes.

Masimo SET will measure oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI) and PVI, which is a measure of the dynamic changes in PI that takes place during the respiratory cycle.

It will allow to solve low perfusion and motion artifact challenges that limit conventional pulse oximetry by improving the working of adaptive filters, which reduce measurement inaccuracy.

Masimo SET enables clinicians to monitor around 100 million patients per year, said the company.

In June, Masimo also secured FDA 510(k) clearance for its Radius-7 wearable, tetherless and noninvasive rainbow monitor.

Featuring rainbow technology, the Radius-7 connects to the Root patient monitoring and connectivity platform.

Radius-7 with Root helps in noninvasive monitoring of more than 10 parameters, including total hemoglobin (SpHb).


Image: Masimo TFA-1 single-patient-use forehead sensor. Photo: courtesy of Masimo.