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Masimo's (MASI) TFA-1 Forehead Sensor Gets FDA Approval

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Irvine, CA-based Masimo Corporation (MASI - Free Report) recently announced that its TFA-1 Single-Patient-Use Adhesive Forehead Sensor has received a 5I0(k) clearance from the U.S. FDA. The sensor monitors patient’s forehead using Masimo’s flagship SET Measure-through Motion and Low Perfusion pulse oximetry.

Meanwhile, Masimo rallied 68.5% over the past one year, whereas the S&P 500 rose only 9.8% over the same time frame. The stock has added roughly 60.3% year to date. Average volume of shares traded over the last three months was remarkable at approximately 696.1K. The stock has a market cap of $3.31 billion.

In fact, for the last six months, the company has a solid return of almost 29.3%, comparing favorably with the Zacks categorized Medical Instruments sub-industry’s negative return of roughly 2.2%. However, Masimo did not follow the favorable market trend, declining 1.9% to close at $66.53 following the news. However, the stock gained 1.6% in after hours trading to close at $67.60.

We are upbeat about the favorable estimate revision trend, with six estimates moving north over the last two months. Notably, the current year estimates for the stock jumped almost 11 cents to $2.13 per share over the same time frame.

Coming back to regulatory progress, TFA-1 medical sensor can be easily used by patients with finger deformities. Additionally, the sensors come without the complexities of ‘cleaning, storage, and inter-department transport’ and strengthen faster detection of ‘desaturation’ and ‘resaturation’ (oxygen saturation measurements).

Masimo develops, manufactures and markets a family of non-invasive monitoring systems. The latest development would significantly fortify the company’s position in the niche markets.

Our Take

Considering the bountiful opportunities for medical sensors in the global market, the FDA go-ahead instills investor confidence on the stock. A research report by the Markets And Markets reveals that niche markets are expected to reach a worth of $15.01 billion globally by 2022, multiplying at a CAGR of 8.5%.

Additionally, Masimo’s long-term growth fundamentals are strong. The company recorded a five-year CAGR of 8.5% for revenues and 9.1% for adjusted earnings per share. Masimo has particularly seen an improvement in earnings over the last three years.

We are also upbeat about Masimo’s flagship SET pulse oximetry business line. Moreover, the recent FDA 510(k) approvals for the Radius 7 wearable and the O3 regional oximetry device are significant positives. Further, launch of Pronto Pulse CO-Oximeter, its next-generation SpHb Spot Check technology, for markets outside the U.S. and next-generation SedLine Brain Function monitoring technology can be considered key catalysts for the long run.

Zacks Rank & Key Picks

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

Better-ranked stocks in the broader medical sector include Addus HomeCare Corporation (ADUS - Free Report) , LHC Group, Inc. and HMS Holdings Corp. . Addus HomeCare and LHC Group sport a Zacks Rank #1 (Strong Buy) while HMS Holdings carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Addus HomeCare has a long-term expected earnings growth rate of approximately 15%. Notably, the stock represents an impressive one-year return of 42.9%.

LHC Group has a long-term expected earnings growth rate of 15%. The company has returned almost 2.8% in the last one month.

HMS Holdings has an expected earnings growth of almost 14.3%. The company posted a promising year-to-date return of 48.5%.

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