Masimo (NSDQ:MASI) announced today that it received FDA 510(k) clearance for two uses of its Radius Tº wearable thermometer.
Irvine, Calif.-based Masimo clearances for Radius Tº cover both prescription use and over-the-counter use for patients and consumers five years of age and older, according to a news release.
Radius Tº includes continuously trending temperature measurements and Bluetooth connectivity for automating remote, continuous body temperature status through a paired connection to a Masimo patient monitoring or telehealth solution in patients. Consumers track temperature status through the Radius Tº smartphone application.
For prescription use, Radius Tº is compatible with the Root patient monitoring and connectivity hub and the Rad-97 patient monitor. It can also be paired with the Masimo SafetyNet app for remote patient management from the home or other care locations.
It offers streamlined workflows, convenient wearability, continuous measurements and wireless connectivity to reduce the need for intermittent manual temperature checks with traditional probes. Each single-patient use thermometer has an eight-day battery life and is shower-proof adhesive.
The product joins the family of Masimo technologies that include Radius PPG and its Masimo SET measure-through motion and low perfusion pulse oximetry, as well as the Radius PCG, which offers mainstream capnography.
“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,” Masimo founder & CEO Joe Kiani said in the release. “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.”