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Medtronic's New Reveal LINQ ICM Gets FDA 510(k) Clearance

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Medical device major, Medtronic plc (MDT - Free Report) recently received the U.S. FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. The device is an advanced cardiac monitor with improved accuracy to better identify abnormal heartbeats.

Notably, Medtronic’s Cardiac & Vascular Group has been leading innovation in cardiac monitoring for a long time, including Reveal, the world’s first loop recorder and Reveal LINQ, the world’s smallest ICM. The company collaborates with a number of clinicians to redesign algorithms and improve detection quality of cardiac monitoring devices.

ICMs basically help physicians to better manage patients at risk for cardiac arrhythmias. Addition of TruRhythm Detection to the Reveal LINQ ICM enables physicians to take quick and accurate decisions while dealing with patients.  

Compared to the predecessor Reveal LINQ ICM, the latest one reduces false heart beat detections by 49%. The device also features the atrial fibrillation (AF – an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient`s heart rhythm over time.  

An added advantage of the new ICM is that it allows physicians to wirelessly monitor a patient’s heartbeat for up to three years at a stretch. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink network.

Given the huge and growing cardiac monitoring market, we believe the latest FDA approval is a major positive for Medtronic. As per a recent MarketsandMarkets report, the global cardiac monitoring market is projected to reach a worth of $28 billion by 2021, at a CAGR of 4.8%. Given the rising rate of cardiac ailments and a critical need to detect them, we expect Medtronic to maintain its dominance in this market going forward.

Other potential players with whom the company shares space in the cardiac monitoring market are Boston Scientific Corporation and GE Healthcare.

Stock Performance

For the last one month, Medtronic has been trading above the Zacks categorized Medical - Products industry. The stock increased 5.8%, higher than the 2.8% gain of the broader industry. The company has also recently achieved CMS coverage for Micra TPS. Thus, the share price trend is expected to continue with Medtronic’s developments at its cardiac segment.

Zacks Rank & Key Picks

Medtronic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are Inogen, Inc. (INGN - Free Report) , Bovie Medical Corporation and Cardiovascular Systems, Inc. . Inogen sports a Zacks Rank #1 (Strong Buy) while the other two companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Inogen gained 77.3% in the last one year in comparison to the S&P 500’s gain of 16.7%. The company has a stellar four-quarter average earnings surprise of over 49.08%.

Bovie Medical surged 49.4% in the last one year in comparison to the S&P 500. It has a four-quarter average earnings surprise of 28.7%.

Cardiovascular Systems gained over 100% in the past one year, better than the S&P 500 mark. The stock has an impressive long-term earnings growth rate of 16.7% for the next five years, compared to the industry average of 15.2%.

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