Dexcom G7 15 Day CGM system cleared by FDA for adults

Published 10/04/2025, 13:38
Dexcom G7 15 Day CGM system cleared by FDA for adults

SAN DIEGO - DexCom, Inc. (NASDAQ:DXCM), a $26.12 billion medical device company with 11.34% revenue growth over the last twelve months, announced the FDA clearance of its Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for adults over the age of 18 with diabetes in the United States. According to InvestingPro analysis, the company's strong financial health score and robust cash flows position it well for this product launch. The new system, which is expected to launch in the second half of 2025, offers a 15.5-day wear period and is claimed to be the most accurate CGM system with an overall Mean Absolute Relative Difference (MARD) of 8.0%.

The Dexcom G7 15 Day builds on the existing Dexcom CGM technology, which has been clinically demonstrated to improve diabetes management by lowering A1C levels and reducing the occurrence of both hyperglycemia and hypoglycemia. Users can expect fewer sensor changes per month, resulting in reduced waste.

This latest device includes features such as being waterproof, the ability to connect directly to an Apple Watch for glucose monitoring, and enhanced mobile app integration with Dexcom Clarity for reviewing glucose patterns and statistics. It also offers a 12-hour grace period for sensor replacement, customizable alert settings, and the ability to share glucose data with caregivers.

According to Satish Garg, MD, from the Barbara David Center for Diabetes at the University of Colorado School of Medicine, recent data supports the G7 15 Day as the most accurate CGM for adults. The system is also designed to integrate with automated insulin delivery systems upon its launch. With a gross profit margin of 60.46% and strong market position, InvestingPro data shows Dexcom maintaining its competitive edge in the medical device sector. Subscribers can access 13 additional ProTips and comprehensive analysis in the Pro Research Report.

The press release claims Dexcom G7 15 Day as the longest-lasting wearable CGM system, a statement based on a study in which approximately 73.9% of sensors lasted the full 15 days. However, it is noted that about 26% of sensors may not last the entire intended duration.

Dexcom has been a pioneer in glucose biosensing technology since 1999, and with this new advancement, it continues to focus on enhancing diabetes management for its users. This information is based on a press release statement from DexCom, Inc. Looking ahead, analysts tracked by InvestingPro forecast 14% revenue growth for FY2025, with the next earnings announcement expected on May 1, 2025. For detailed financial analysis and Fair Value estimates, investors can access the comprehensive Pro Research Report, available for over 1,400 US stocks.

In other recent news, DexCom has been in the spotlight with several key developments. Mizuho Securities initiated coverage of DexCom with an Outperform rating and set a price target of $85, citing strong adoption rates for its continuous glucose monitoring (CGM) technology and positive feedback on its G7 sensor. This is complemented by Citi maintaining its Buy rating and a $104 target, despite a recent FDA Warning Letter addressing manufacturing practices for the G6 and G7 CGMs. The FDA's concerns are not expected to impact DexCom's revenue or margin guidance, and the company is actively addressing the outlined issues.

Additionally, DexCom announced a change in its auditing firm, replacing Ernst & Young LLP with Deloitte & Touche LLP for the fiscal year ending December 31, 2025. There were no disagreements reported with EY regarding accounting principles. Furthermore, DexCom has appointed Jon Coleman as its new chief commercial officer, bringing extensive experience from his previous roles at Masimo Corporation and Pfizer. In another strategic move, Renée Galá has joined DexCom's Board of Directors, adding her expertise in financial and strategic leadership from her tenure at Jazz Pharmaceuticals. These appointments are part of DexCom's ongoing efforts to strengthen its leadership team and expand its impact in the healthcare sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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