The Food and Drug Administration (FDA) has given Radius Tº ™, a portable, wireless thermometer 510 (k) approval for continuous, non-invasive measurement of body temperature for both prescription and over-the-counter (OTC) patients for 5 years. Age and older.
Radius Tº is designed to measure body temperature 24/7 with an accuracy of ± 0.18 ° F in the range of 77 ° F to 109.4 ° F. The wireless thermometer is a waterproof sensor that is placed on the upper chest below the left collarbone. Each sensor has a battery life of 8 days.
The body temperature data recorded by Radius Tº is transmitted via Bluetooth® connectivity to a Masimo patient monitoring or telemedicine solution or via the Masimo Radius Tº smartphone app. For hospital use, Radius Tº is compatible with both the Root® Patient Monitoring and Connectivity Hub and the Rad-97® patient monitor as part of the Masimo Hospital Automation ™ platform.
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Radius Tº is available as a 3-pack sensor for use in hospitals and at home. The Masimo Radius Tº app is available for iOS and Android devices.
Joe Kiani, Masimo Founder and CEO, said, “Radius Tº was first made available in the US under an FDA’s COVID-19 enforcement policy for thermometers as part of Masimo SafetyNet – where it is quickly showing its value in improving workflows by clinicians through its continuous, remotely accessible body temperature measurements for patients recovering or quarantined at home. Now, with FDA 510 (k) approval, the Radius Tº is expanding its availability to physicians and consumers to monitor and track body temperature in all thermometer applications. “
References
- Masimo announces FDA 510 (k) approval of Radius Tº ™ for prescription and over-the-counter use. [press release]. Irvine, CA: Massimo; June 21, 2021.
- Masimo. Radius Tº ™. https://www.masimopersonalhealth.com/products/radius-t-wearable-thermometer. Accessed June 21, 2021.
This article originally appeared on MPR
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Diagnostic tests general medicine
