Masimo’s wearable device passes USFDA clearance

The wearable, wireless Masimo Radius-7 offers continuous, noninvasive patient monitoring with comfort and freedom of movement


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Masimo announced FDA 510(k) clearance of Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo's rainbow SET technology.

With rainbow SET noninvasive measurements, Radius-7 with Root can alert clinicians - at the bedside or remotely, through the Masimo Patient SafetyNet remote monitoring and notification system - of critical changes in a patient's oxygen saturation and pulse rate - even during states of motion and low perfusion - as well as respiration through acoustic respiration rate (RRa).

Lightweight at only 0.34 lbs (155g), the Radius-7 attaches to the patient's arm or can be 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.

And the Radius-7's wireless communication functionality - either short-range via Bluetooth back to Root or with upgradeable WiFi for long-range communication - ensures the patient can be continuously monitored and connected to caregivers wherever they are in the hospital.


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