Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the prescription and over-the-counter (OTC) use of Radius Tº wearable and wireless thermometer for patients and consumers five years and older.

With continuously trending temperature measurements and Bluetooth connectivity, the Radius Tº thermometer is used for the measurement of body temperature continuously and noninvasively.

It will help automate remote and continuous body temperature status for clinicians via its paired connection to a Masimo patient monitoring or telehealth solution, as well as for consumers through the Masimo Radius Tº smartphone application.

For prescription application, Radius Tº can be used with both the Root Patient Monitoring and Connectivity Hub and the Rad-97 patient monitor for use in the hospital under the Masimo Hospital Automation platform.

Masimo SafetyNet app will help connect the Radius Tº thermometer to a patient’s smartphone.

Radius Tº wireless thermometer, which is single-patient use, will help minimise the risk of cross-contamination between patients.

The advanced algorithm is used by the Radius Tº to deliver continuous body temperature measurements, which are approximations of sublingual temperatures captured from an oral probe.

The company’s advanced thermometer will enable clinicians to manage and assess a patient’s high fever risks and fever progress over time.

Radius Tº can be incorporated into the Masimo Hospital Automation platform via Root or Rad-97 to facilitate the automatic transfer of continuous body temperature data to a hospital’s electronic medical records (EMRs) or surveillance monitoring solution.

For consumers, Radius Tº continuously enables to measure temperatures and transmit data and customisable temperature notifications to the Masimo Radius Tº app on the user’s smartphone.

Radius Tº can be placed on the upper chest, helping to avoid the potential discomfort of other wearable devices that depend on placement in the armpit.

Masimo founder and CEO Joe Kiani said: “Radius Tº was first made available in the U.S. under an FDA Covid-19 enforcement policy for thermometers as part of Masimo SafetyNet – where it quickly demonstrated its value in improving clinician workflows through its continuous, remotely accessible body temperature measurements for patients recovering or quarantined at home.”