Press release
Masimo Announces FDA Clearance of the Rad-G® with Temperature
IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced that the Rad-G® with Temperature has received FDA 510(k) clearance. Rad-G with
About this update from Masimo Corporation
[{"type":"text","content":" IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today announced that the Rad-G® with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically proven SET® pulse oximetry, respiration rate from the pleth (RRp®), and other important parameters alongside non-contact infrared clinical thermometry. With its long-lasting rechargeable battery, robust rubber casing, light weight, and the added convenience of integrated noninvasive forehead thermometry, Rad-G with Temperature makes it easier for care teams to quickly measure vital signs using a single, compact, portable device and make informed decisions anywhere patient assessment is needed. 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.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230418005553/en/Masimo Rad-G® with Temperature (Photo: Business Wire)\nJoe Kiani, Founder and CEO of Masimo, said, “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 five billion people on our planet that to date have not had access to pulse oximetry, let alone SET® pulse oximetry. 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. With this FDA clearance, Rad-G with Temperature can now be deployed across the U.S., in addition to many other parts of the world, helping support clinicians in almost any care scenario.”\n\n\nThe infrared thermometry offered by Rad-G with Temperature provides a host of benefits. Rad-G’s thermometer is non-contact and does not require probe covers or other disposable accessories. Its integration into the Rad-G platform eliminates the need for clinicians to locate a separate clinical thermometer to take body temperature measurements and ensures that many people can be seamlessly and efficiently screened for temperature, with one-touch op...