Masimo wireless, wearable patient monitor cleared by FDA

Masimo ($MASI) has gained FDA clearance for its wireless, wearable patient monitor, Radius-7. The device connects to Root, Masimo's open architecture, patient monitoring and connectivity platform that links a variety of devices regardless of company origin, which the company expects to be ubiquitous.

The wireless Radius-7 offers continuous, noninvasive patient monitoring with the freedom of movement.--Courtesy of Masimo

Radius-7 tracks patient oxygen saturation, pulse rate and acoustic respiration rate. It can connect at the patient bedside via Bluetooth or at home through an upgrade for WiFi capability. So, patients can be monitored and ambulatory in the hospital and in a home care setting with the same device. The Radius-7 is worn on a patient's arm using a single-use armband and can be removed and placed next to the patient.

"Radius-7 is a lightweight multi-function wearable device that has a wireless link to our Root monitor. Patients wearing the Radius-7 will have the benefit of always-on monitoring so that the health and data integrity are not jeopardized when around within the hospital. Studies have shown that patient mobility is a key factor in more rapid patient recovery," summed up Masimo founder, chairman and CEO Joe Kiani on an August earnings call.

Radius-7 received a CE mark in July and is already sold in some European countries.

The device connects to Masimo's Patient SafetyNet remote monitoring and notification system that can alert healthcare providers of critical changes. Via the Root platform, patient data can be collected from multiple devices such as IV pumps, ventilators, beds and other patient monitors.

Masimo is confident that Root will become fundamental to healthcare. "I think Root should do to this industry what PCs did to basically home and a distributed computing," said Kiani on an October earnings call.

"I think Root, with its connectivity prowess, with its open architecture to take any third-party sensors as well as our own innovation and this very, very rich user interface and now with Radius-7. And maybe even more importantly, the price that we're willing to charge for it, which is very low. I really think it should become ubiquitous," he concluded.

Masimo expects to have about $585 million in 2014 revenue; it's focused on non-invasive patient monitoring technologies.

- here is the release

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