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Masimo Gets FDA Clearance for Rad-67 Monitoring Device

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Masimo Corporation MASI recently announced that it has received a 510(k) clearance from the FDA for its Rad-67 Pulse CO-Oximeter. The device includes Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusable Sensor.

Rad-67 is a compact, mobile spot-check monitoring device that facilitates rainbow noninvasive hemoglobin measurement as well as Measure-through Motion and Low Perfusion SET pulse oximetry.

Investors should note that Pulse oximetry is a test to measure the oxygen level (oxygen saturation) of the blood. The regulatory clearance will enable the company to provide noninvasive portable hemoglobin spot-check monitoring.

Easy Method for Historical Data Review

Interestingly, Rad-67 conducts reviews on data directly on the device. The device is equipped with an in-built wireless connectivity that transfers a patient’s medical history data to an EMR.

The process is conducted through unique patient identifiers to help improve organization of records and workflow. Per management, this alleviates the possibility of transcription errors or unfinished case records.

Masimo: A Leading Player in Pulse Oximetry

Masimo is a global pioneer in the field of highly-advanced non-invasive monitoring technologies.

The company’s flagship Signal Extraction Technology (SET) pulse oximetry or SET pulse oximeter solution successfully eliminates the limitations of conventional mediums. Masimo’s rainbow SET technology is gaining traction owing to rapid product development.

Market prospects

Per Grand View Research, the global pulse oximeters market is expected to witness a CAGR of 6.3% and reach $2.8 billion by 2025.

Some of the key players in the niche space are Covidien, CareFusion Corp and GE Healthcare.

Other Favorable Regulatory Approvals

Recently, Masimo announced that its Next Generation SedLine brain function monitoring for pediatric patients has received CE marking.SedLine enables clinicians to monitor the state of the brain under anesthesia.

In January, the med-tech giant received FDA’s approval for RRp, Respiration Rate from the Pleth, on the MightySat Rx Spot-Check Fingertip Pulse Oximeter. The Mightysat Rx is the first fingertip pulse oximeter with SET. It is also the first device to measure respiration rate.

Price performance

In the past year, Masimo has outperformed the industry it belongs to. The stock has surged 57.2% compared with the industry’s rise of 11.9%.

Zacks rank and Other Key Picks

Currently, Masimo carries a Zacks rank of #2 (Buy).

Some other top-ranked stocks in the broader medical space are Stryker Corporation SYK , Penumbra, Inc PEN, and Varian Medical Systems, Inc VAR. Notably, the stocks currently carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Stryker's long-term earnings growth rate is projected to be 10%

Penumbra’s long-term earnings growth rate is projected to be 20.9%.

Varian’s long-term earnings growth rate is projected to be 8%.

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