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Masimo's Neonatal RD SET Pulse Oximetry Sensors Get FDA Nod

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Masimo Corporation MASI received the FDA’s nod for its RD SET sensors to be used with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry. The procedure is aimed at offering improved oxygen saturation (SpO2) accuracy specifications for neonatal patients weighing less than 3kgs.

Masimo stated that SpO2 accuracy specifications of the updated version of RD SET sensors greatly improved, thus enabling care providers to monitor the oxygenation status of neonates with greater confidence.

Notably, the upgraded features were first incorporated in 2018 into RD SET sensors only for patients weighing more than 3kgs. With the recent approval, the entire prenatal patient population within the United States have been brought under the purview.

With the receipt of the FDA clearance, the company aims to strengthen its core business of Measure-through Motion and Low Perfusion pulse oximetry monitoring, commonly known as Masimo SET (Signal Extraction Technology) pulse oximetry.



Significance of the Approval

Masimo’s SET pulse oximetry has been proved to be an improvement compared with other pulse oximetry technologies currently available in the market based on various independent and objective studies. The SET pulse oximetry will thus provide clinicians with increased sensitivity and specificity to make critical patient care decisions.

Notably, RD SET sensors are designed to augment patient comfort, optimize clinician workflows and help hospitals meet green initiatives. Most importantly, these sensors along with Velaid SofTouch are most suited for use on the delicate skins of newborns and pre-term babies.

Industry Prospects

Per a report by Grand View Research, the global pulse oximeters market size was valued at $1.8 billion in 2018, and is projected to witness a CAGR of 6.3% between 2019 and 2025. Factors like the huge burden of healthcare costs and the lack of defined reimbursement policies are likely to drive the market. Other contributing factors like the increasing importance of monitoring patients in treatment regime and diagnosis along with extensive occurrence of target diseases are likely to drive the market.

Given the market potential, the FDA clearance is well-timed.

Recent Developments

In December 2019, Masimo and announced the expansion of its licensing partnership with Dräger, thus enabling Dräger to integrate additional Masimo measurement technologies. The agreement was expanded to improve the assessment of brain function, oxygenation, and ventilation status by clinicians.

In October 2019, Masimo’s Radius Capnography (a portable real-time capnography, with wireless Bluetooth connectivity) received the CE marking.

Masimo announced three additional indices (delta cHb, delta HHb and delta O2Hb) for O3 Regional Oximetry in September 2019. These will provide care providers additional visibility in changes in underlying oxyhemoglobin and deoxyhemoglobin components, which are used to estimate cerebral oxygen saturation (rSO2).

Price Performance

Shares of Masimo have gained 53.8% in the past year compared with the industry’s 28.4% growth.

Zacks Rank & Stocks to Consider

Currently, the company carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Haemonetics Corporation HAE, National Vision Holdings, Inc EYE and Medtronic plc (MDT - Free Report) .

Haemonetics currently flaunts a Zacks Rank #1 (Strong Buy) and has a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2 (Buy).

Medtronic’s long-term earnings growth rate is estimated at 7.4%. It currently carries a Zacks Rank #2.

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