Masimo Corp. (MASI) Announces Receipt of CE Mark for Rad-97 Pulse CO-Oximeter

October 6, 2016 8:05 AM EDT

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Masimo (Nasdaq: MASI) announced today the CE marking of the Rad-97 Pulse CO-Oximeter. Rad-97 offers the same Measure-through Motion and Low Perfusion™ SET® pulse oximetry and upgradeable rainbow SET™ technology as the Radical-7® Pulse CO-Oximeter – in a versatile standalone monitor configuration.

Rad-97 features a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. Rad-97 provides both built-in wireless connectivity, via Wi-Fi and Bluetooth®, and built-in wired options, including Ethernet, USB, and Nurse Call Interface connections. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed.

In select markets outside the United States, Rad-97 will be available with an optional camera, which will be used in conjunction with Masimo Patient SafetyNet™*. The camera includes a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. The system will be able to use the hospital’s existing IT network and to provide additional viewing of images in the same care area. Through Rad-97, it will be possible to connect other devices a patient may be using, such as glucometers and scales, to Patient SafetyNet and to remotely allow for interaction between clinicians and patients or other clinicians.

Like Radical-7, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements total hemoglobin (SpHb®), methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), and oxygen content (SpOC™). In select markets outside the United States, additional parameters such as Oxygen Reserve Index™ (ORi™) and respiration rate from the pleth (RRp™) are available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

“Rad-97 brings our core SET® and rainbow® technologies to a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes,” said Joe Kiani, Founder and CEO of Masimo. “We’ve engineered Rad-97 to take advantage of the latest advances in adaptability and connectivity, packaging Masimo’s industry-leading noninvasive technology in a cost-effective monitor that will make it more accessible and useful to clinicians and patients than ever.”

ORi and RRp parameters and the camera feature do not have 510(k) clearance and are not available in the U.S.

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