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Masimo's Radius 7 Wearable Monitor Gets FDA 510 (k) Nod

Published 06/29/2016, 04:48 AM
Updated 07/09/2023, 06:31 AM

Masimo Corporation (NASDAQ:MASI) recently announced the receipt of FDA 510 (k) approval for the Radius 7 wearable, tetherless, non-invasive rainbow monitor device. This follows the recent approval of the O3 regional oximetry device, which uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.

Radius 7 connects to the Root patient monitoring and connectivity system. Per Masimo, “Radius-7 is lightweight, weighing only 0.34 lbs, and attaches to the arm, thus allowing untethered monitoring whether a patient is in or out of bed – which also reduces the need for nursing assistance, as there is no need to disconnect from or reconnect to a bedside monitor.”

The Radius 7 launch will solidify Masimo’s presence in the wearable device market. According to International Data Corporation’s (IDC) Worldwide Quarterly Wearable Device Tracker, worldwide shipments of wearable devices are expected to reach 110 million by the end of 2016 with 38.2% growth over 2015.

This massive growth will not only be driven by an expanding line-up of products from different vendors, but also from fast-growing consumer awareness. The IDC noted that watch and wristband (Radius 7 part of this group) shipments will reach a combined 100 million in 2016, up from 72.2 million in 2015.

Radius 7 has tremendous benefit for clinicians as it allows non-invasive monitoring of 10 parameters including total hemoglobin (SpHb), which is a first for any wearable device available in the market. The constant monitoring will help clinicians to take more timely and informed decision particularly in case of neuro and orthopedic surgeries, where timely blood transfusion is crucial for the well being of patients.

We believe Masimo’s innovative product portfolio is a key catalyst. Masimo recently launched Pronto Pulse CO-Oximeter, its next-generation SpHb Spot Check technology, for markets outside the U.S. The company also unveiled its next-generation SedLine Brain Function monitoring technology at the European Society of Anaesthesiology’s (ESA) 2016 Euroanaesthesia Congress in London.

Increasing adoption of non-invasive patient monitoring technology will help the company gain market traction. The company’s SET pulse oximetry business holds considerable growth opportunities in international markets.

Zacks Rank & Other Key Picks

Masimo sports a Zacks Rank #1 (Strong Buy).

Some other well-placed stocks in the medical space are CryoLife (NYSE:CRY) , IRadimed (NASDAQ:IRMD) and Halyard Health (NYSE:HYH) . All three stocks sport a Zacks Rank #1.



MASIMO CORP (MASI): Free Stock Analysis Report

IRADIMED CORP (IRMD): Free Stock Analysis Report

CRYOLIFE INC (CRY): Free Stock Analysis Report

HALYARD HEALTH (HYH): Free Stock Analysis Report

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