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Masimo obtains FDA 510(k) approval for new wireless monitor Radius-7

Masimo has obtained 510(k) approval from the US Food and Drug Administration for its new wireless monitor, Radius-7, for the Root patient monitoring and connectivity platform.

SET

Featuring firm’s rainbow SET technology, Radius-7 with Root can alert clinicians at the bedside or remotely through the Masimo Patient SafetyNet remote monitoring and notification system.

The light weight Radius-7 can be attached to the patient’s arm or placed alongside the patient in their bed, allowing untethered monitoring while they are in bed or out.

With no need to disconnect and reconnect the cable to get out of bed, the Radius-7 reduces the need for nursing assistance, according to the company.

It can be connected to caregivers wherever they are in the hospital, through Bluetooth to Root for short-range and WiFi for long-range communication.

In 1995, the company introduced measure-through motion and low perfusion pulse oximetry, Masimo SET, which virtually eliminated false alarms and increased pulse oximetry’s ability to help clinicians detect life-threatening events.


Image: The wearable, wireless Masimo Radius-7 offers continuous and noninvasive patient monitoring with comfort and freedom of movement. Photo: courtesy of Masimo Corporation.