Masimo Receives FDA 510(k) Clearance for Prescription and OTC Use of Radius Tº Thermometer

Masimo FDA 510(k) Clearance Radius Tº Thermometer

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

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Featuring continuously trending temperature measurements and Bluetooth® connectivity, Radius Tº automates remote, continuous body temperature status for clinicians through its paired connection to a Masimo patient monitoring or telehealth solution, and for consumers through the Masimo Radius Tº smartphone application.

Radius Tº is part of the growing family of tetherless Masimo technologies that includes Radius PPG™, which offers Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and Radius PCG, which provides mainstream capnography.

For prescription use, Radius Tº is compatible with both the Root® Patient Monitoring and Connectivity Hub and the Rad-97 patient monitor for use in the hospital, as part of the Masimo Hospital Automation platform. Radius Tº can also be paired to a patient’s smartphone using the Masimo SafetyNet app, for remote patient management from the home or other care location, reports BusinessWire.

Using a proprietary algorithm, Radius Tº provides continuous body temperature measurements that are approximations of sublingual temperatures captured from an oral probe. Radius Tº supports continuous body temperature performance that goes beyond simple skin surface temperature measurements, and remains reliable even when environmental temperatures are fluctuating. Radius Tº provides trended data to help clinicians manage and review a patient’s high fever risks and fever progress over time.

A woman sleeping
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Radius Tº is easily integrated into the Masimo Hospital Automation platform, through Root or Rad-97, allowing automatic transfer of continuous body temperature data to a hospital’s electronic medical records (EMRs) or surveillance monitoring solution, thus streamlining clinicians’ ability to gain a more insightful picture of each patient’s physiological status, regardless of the clinician’s physical location.

Radius Tº continuously measures temperatures and seamlessly transmits data and customizable temperature notifications to the Masimo Radius Tº app on the user’s smartphone – helping caregivers, such as parents, monitor loved ones’ temperatures even while they sleep and providing continuous insight into changes and trends in their temperature. In addition, Radius Tº is applied comfortably on the upper chest, avoiding the potential discomfort of other wearable devices that rely on placement in the armpit.

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Joe Kiani, Founder and CEO of Masimo, 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. Now, with the FDA 510(k) clearance, the availability of the Radius Tº is being expanded for use by both clinicians and consumers to help monitor and track body temperatures in all thermometer applications.”

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Cathy Russey
Cathy Russey () is Online Editor at WT | Wearable Technologies and specialized in writing about the latest medical wearables and enabling technologies on the market. Cathy can be contacted at info(at)