FDA Clears Masimo Rad-G Pulse Oximeter with Temperature

The US FDA granted 510(k) clearance to Masimo’s Rad-G with Temperature, a handheld monitor that provides SET pulse oximetry, respiration rate from the pleth (RRp), and other important parameters alongside non-contact infrared clinical thermometry. 

Rad-G with Temperature is designed for use in a variety of settings, including physicians’ offices, outpatient services, urgent care facilities, wellness clinics, and in first-responder scenarios, both indoors and in the field.

“With Rad-G, we set out to create an accessible, high-quality care solution that could be used in a multitude of care settings to serve the 5 billion people on our planet that to date have not had access to pulse oximetry, let alone SET pulse oximetry,” says Joe Kiani, founder and CEO of Masimo, in a press release. “With the addition of temperature measurements, Rad-G is more versatile than ever, streamlining the assessment of multiple key vital signs. Having a product that is light, small, multifunctional, and ‘accurate when you need it most’ is crucial, and Rad-G was designed to be just that.”

In addition to temperature measurements and Masimo SET oxygen saturation (SpO2) and pulse rate, the same SpO2 sensor can be used to monitor respiration rate from the plethysmograph, with RRp. Difficulty breathing and fever are generally considered two of the earliest signs of patient deterioration, and Masimo believes that the availability of RRp and thermometry on Rad-G may play a role in assisting clinicians and public health officials as they seek to combat numerous types of illnesses, including pneumonia and other respiratory viruses.

With the FDA clearance, Rad-G with Temperature can now be deployed across the US.

First developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device for use in pneumonia screening, Rad-G with Temperature originally launched outside the US. Since its introduction in Europe, more than 100 global customers have adopted the device to help them assess patient status in a variety of care settings. 

Among other care scenarios, the National Health Service England, which provides the majority of healthcare in England, uses the technology to support primary care assessments of unwell children in physician’s offices across the country. In a survey of 109 National Health Service England clinicians whose primary care facilities were using more than 4,000 Rad-G with Temperature devices, 85% of respondents scored Rad-G with Temperature as “quite easy” or “very easy” to use.