Boston Scientific Corporation BSX recently received the FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor (“ICM”) System. Notably, ICM is a new long-term diagnostic device which is implanted in patients to detect arrhythmias (a condition in which the heart beats with an irregular or abnormal rhythm) associated with conditions such as atrial fibrillation.
Boston Scientific is currently on track with an immediate limited market launch of the LUX-Dx ICM System in the United States. A full launch of the product will commence later this year.
With the latest regulatory clearance, the company aims to strengthen its Cardiac Rhythm Management (“CRM”) business across the globe. Notably, the CRM business is a component of the company’s broader Rhythm and Neuro arm.
More on the ICM System
The LUX-Dx ICM System is designed to detect and verify potential arrhythmias before alerting physicians. This enables to provide actionable data to the physicians for devising treatment plans.
The system is also equipped with remote programming capabilities through the LATITUDE Clarity Data Management System website. This capability enables the caregivers to adjust event detection settings without necessitating an in-person patient appointment, unlike other currently available ICMs.
Significance of the Approval
Per management, the design of the LUX-Dx ICM System will allow physicians to fast-track their clinical decisions and focus more on patient outcomes due to availability of vital patient information. This will also enable them to identify any false positive detections without compromising sensitivity.
The company believes that the addition of the latest device along with its existing products and services will significantly boost its diagnostic portfolio.
Per a report by Allied Market Research, the global ICM market was valued at $410.4 million in 2016 and is anticipated to reach $678.3 million by 2023, at a CAGR of 7.4%. Factors like growing demand for ICM devices to continuously monitor the heart, rising incidences of cardiovascular diseases and technological advancements are likely to drive the market.
Given the market potential, the regulatory clearance seems strategic for Boston Scientific’s CRM business.
Recent Developments in Rhythm and Neuro Arm
Of late, Boston Scientific has witnessed few important developments in its Rhythm and Neuro segment.
In June, the company announced the U.S. launch of its tool for monitoring the effect of radiofrequency energy delivery, the DIRECTSENSE Technology. The launch was preceded by its FDA approval in April. This launch is expected to provide a significant boost to the company’s Electrophysiology business, which is a segment of the broader Rhythm and Neuro arm.
Moreover, in May, the company announced the final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator System.
Shares of the company have gained 7.6% in the past three months compared with the industry’s 11.2% growth and the S&P 500’s 17.2% rise.
Zacks Rank & Key Picks
Currently, Boston Scientific carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated DGX, Laboratory Corporation of America Holdings LH or LabCorp and QIAGEN N.V. QGEN.
Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
LabCorp’s long-term earnings growth rate is estimated at 6.1%. The company presently has a Zacks Rank #2 (Buy).
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.1% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Quest Diagnostics Incorporated (DGX) : Free Stock Analysis Report
QIAGEN N.V. (QGEN) : Free Stock Analysis Report
Boston Scientific Corporation (BSX) : Free Stock Analysis Report
Laboratory Corporation of America Holdings (LH) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research