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DexCom's (DXCM) New G6 Pro CGM System Gets FDA Approval

Published 10/08/2019, 10:31 PM
Updated 07/09/2023, 06:31 AM
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DexCom, Inc. (NASDAQ:DXCM) announced that the FDA has approved its G6 Pro Continuous Glucose Monitoring (“CGM”) System for use on patients (aged two years and up). This further fortifies DexCom’s foothold in the CGM market and boosts its broad product portfolio.

The Dexcom G6 Pro is the first and only single use, professional CGM system that gathers real-time glucose data for patients. Notably, the data gathered by the system enables physicians to adjust a patient’s diabetes therapy plan with precision and customization.

The continuous glucose readings warn patients of dangerously high and low glucose levels while the system’s clarity allows providers to generate interactive reports and review glucose patterns.

Solid Product Portfolio

DexCom’s broad product portfolio lends it a competitive edge in the U.S. MedTech space.

Notably, the FDA’s approval to the CGM system — DexCom G4 Platinum — has significantly bolstered the company’s top line. Also, the FDA has already granted a De Novo request for the DexCom G6 CGM System. In fact, management expects to bring G6 to Canada later in 2019.

Per management, the team at DexCom is working toward finalizing the G7 CGM system rollout and projects a late 2020 or early 2021 initial launch.

Wearable Medical Devices in Limelight

More than half of the American populace uses wearable devices to track calories, measure oxygen saturation, monitor sleep and pulse rates.

In fact, the advent of smartphones has prompted tech behemoths to apply medical uses to phone-connected and body-mounted sensors.

For instance, Apple’s (NASDAQ:AAPL) FDA-approved Watch Series 4 captures an electrocardiogram seamlessly. Meanwhile, Fitbit, Inc.’s (NYSE:FIT) wearable, Charge 3, which is available globally, features 24/7 PurePulse heart rate technology that is more advanced, with more than nine trillion minutes of heart rate data.

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Market Prospects

MarketWatch predicts the CGM market to reach a worth of $1.32 billion by 2025 at a CAGR of 15.8%. Rising prevalence of diabetes globally and surge in instant glucose level testing are the factors that drive the market.

Price Performance

In a year’s time, this Zacks Rank #3 (Hold) company has rallied 27.4% compared with the industry’s 0.6% increase.

A Key Pick

A better-ranked stock in the broader medical space is Varian Medical Systems (NYSE:VAR) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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

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DexCom, Inc. (DXCM): Free Stock Analysis Report

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