Masimo’s (MASI) Wearable Wireless Thermometer Gets FDA Nod

Masimo Corporation MASI recently announced receipt of the FDA 510(k) clearance for its wearable, wireless thermometer […]

Masimo Corporation MASI recently announced receipt of the FDA 510(k) clearance for its wearable, wireless thermometer — Radius T° — for both prescription and over-the-counter use for patients and consumers above the age of five. The thermometer measures body temperature continuously and non-invasively, and features continuously trending temperature measurements and Bluetooth connectivity.

For investors’ note, Radius T° automates remote, continuous body temperature status for clinicians via its paired connection to a Masimo patient monitoring or telehealth solution. For consumers, this is made possible through the Masimo Radius T° smartphone application.

It should be noted that Radius T° was first made available in the United States under an FDA COVID-19 enforcement policy for thermometers as part of Masimo SafetyNet.

With the latest regulatory clearance, Masimo is expected to strengthen its position in the global Home Wellness and Monitoring products space.

Few Words on Radius T°

Radius T° belongs to the expanding suite of tetherless Masimo technologies that includes Radius PPG and Radius PCG.

Further, as part of the Masimo Hospital Automation platform, Radius T° is compatible with both the Root Patient Monitoring and Connectivity Hub, and the Rad-97 patient monitor for use in hospitals. For remote patient management from home or other care locations, Radius T° can be paired to a patient’s smartphone using the Masimo SafetyNet app.

Significance of the Approval

Radius T° continuously measures temperature and effortlessly transmits data and customizable temperature notifications to the Masimo Radius T° app on the user’s smartphone. This aids in monitoring temperature even during sleep, and provides continuous insight into changes and trends in temperature. Additionally, Radius T° can be applied comfortably on the upper chest, thus avoiding the potential discomfort of other wearable devices that rely on placement in the armpit.

Per management, Radius T° has already established its efficacy during the pandemic when it improved clinician workflows via its continuous, remotely accessible body temperature measurements for patients recovering or quarantined at home. Following the FDA approval, the expanded use is expected to help monitor and track body temperatures in all thermometer applications.

Industry Prospects

Per a report by MarketsAndMarkets, the global patient monitoring devices market is projected to reach $55.1 billion by 2025 from $36.4 billion in 2020 at a CAGR of 8.6%. Factors like technological advancements and growing preference for telehealth services amid the pandemic are expected to drive the market.

Given the market potential, the recent FDA clearance is expected to significantly boost Masimo’s business worldwide.

Recent Developments

Of late, Masimo has been witnessing few developments across its businesses.

The company, this month, announced the findings of a study which evaluated the utility and impact of Masimo Patient SafetyNet, that was published in the Journal of PeriAnesthesia Nursing.

Masimo, in May, announced the results of a study which found that the use of Patient SafetyNet with Masimo SET Pulse Oximetry and Acoustic Respiratory Rate monitoring significantly reduces nursing workload related to postoperative respiratory assessment. This result was also published in the Journal of PeriAnesthesia Nursing.

The same month, the company announced the publication of a study in the Journal of Anesthesia & Clinical Research, in which researchers assessed the utility of Masimo O3 Regional Oximetry to aid in monitoring septic shock patients admitted to the ICU.

Price Performance

Shares of the company have gained 5.5% in the past year compared with the industry’s 18.7% growth and the S&P 500’s 35.1% rise.

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