Masimo's Multigas Monitoring Module Gets 510(k), CE Mark - Analyst Blog

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Masimo Corporation ( MASI ) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as well as CE Mark approval for its ISA OR+ multigas monitoring module. Following the approvals, the company announced a global launch of the module.

ISA OR+ multigas monitoring is a Masimo Open Connect (MOC-9) Module for the Root patient monitoring and connectivity platform. The device supports anesthesia agent identification and ventilation management.

During general anesthesia, the ISA OR+ supervises the inhaled and exhaled concentration of five anesthetic gas agents, carbon dioxide, nitrous oxide and oxygen, apart from the respiration rate. Masimo's latest Root module is appropriate for monitoring adult, pediatric or infant patients in a range of clinical environments including the operating room and intensive care unit.

The Root patient monitoring and connectivity platform integrates Masimo's parameters in an integrated, clinician-centric platform. When technology modules are connected with Root, multiple additional parameters are available including Masimo SET pulse oximetry, noninvasive and continuous hemoglobin (SpHb), PVI, SedLine brain function monitoring, and O3 Regional Oximetry.

Masimo's lightweight Radius-7 monitor, which is designed to monitor patients while allowing them freedom of movement, was cleared by the FDA earlier this month. With Masimo's Radius-7 wireless monitor and multiple connectivity options, Root integrates multiple streams of data and simplifies patient care workflows, empowering caregivers to help make quicker patient assessments, earlier interventions and better clinical decisions.

The Root platform is also designed for third-party measurement expansion to allow other companies to expand the platform with their own measurements through MOC-9, following Masimo's established development and validation process.

However, the monitoring products market remains quite competitive with a lot of companies vying for substantial market share. Masimo faces stiff competition from Covidien ( COV ).

Currently, Masimo carries a Zacks Rank #3 (Hold).

Better-ranked medical instruments makers include Edwards Lifesciences Corp. ( EW ) and Globus Medical Inc. ( GMED ). Both these stocks carry a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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