Masimo wins FDA nod for Rad-97 pulse oximeter, launches in US

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-97 pulse co-oximeter and launched the device in the US.

The Irvine, Calif.-based company said the newly released Rad-97 features NomoLine capnography and noninvasive blood pressure monitoring technology from SunTech Medical, as well as its own continuous monitoring and SET pulse oximetry with upgradable rainbow tech.

The Rad-97 features a multi-touch dispaly, a small footprint and easy configuration, Masimo touted, with built-in enterprise WiFi and supported Bluetooth wireless connections to related compatible devices including thermometers, glucometers and weight scales.

“We’re excited to bring the easy-to-use, compact Rad-97 to the US. Rad-97 brings together our core SET and rainbow technologies with advanced, workflow-enhancing connectivity solutions. We believe it will be an indispensable addition to many healthcare environments, including lower-acuity settings in hospitals, alternate care, and telehealth,” founder & CEO Joe Kiani said in a press release.

Last month, Masimo said that the Dubai Health Authority implemented its Patient SafetyNet remote monitoring and clinician notification system at 2 Dubai hospitals.

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