SAN DIEGO, April 16, 2025 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP, a leading stockholder rights law firm, has initiated an investigation into the board members and executive officers of DexCom, Inc. (NASDAQ: DXCM) for potential breaches of fiduciary duties and violations of the federal securities laws. What is Johnson Fistel Investigating? Between April 28, 2023 and June 5, 2024, certain DexCom insiders caused the company to issue false and misleading public statements regarding its expansion strategy and ...

Core Insights - DexCom, Inc. has received FDA clearance for its G7 Continuous Glucose Monitoring (CGM) system, which is the longest-lasting and most accurate CGM approved in the U.S. for individuals over 18 with diabetes [1][2] Company Developments - The G7 system features a 15-day wear duration, improved accuracy with a Mean Absolute Relative Difference of 8%, and enhanced user experience through a redesigned mobile app [6][7] - The FDA clearance is expected to boost DexCom's market position, allowing for an expanded customer base and increased recurring revenue from sensors [4] - DexCom's current market capitalization stands at $26.21 billion [5] Competitive Landscape - The G7 CGM system's 15-day wear time aligns it with Abbott's Libre 2 CGM system, enhancing its competitive edge in the diabetes technology market [4][9] - DexCom is also pursuing partnerships with insulin pump manufacturers to ensure compatibility with automated insulin delivery systems [9] Industry Outlook - The global digital diabetes management market is projected to grow from $18.9 billion in 2023 to $35.8 billion by 2028, reflecting a compound annual growth rate of 13.6% [11] - Key drivers of this growth include advancements in diabetes care solutions, the popularity of connected devices, and the adoption of cloud-based solutions [12]

The U.S. Food and Drug Administration approved DexCom, Inc.’s DXCM Dexcom G7 15-Day Continuous Glucose Monitoring System for people over 18 with diabetes.With an overall Mean Absolute Relative Difference (MARD) of 8.0%, Dexcom G7 15 Day builds on the performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range.Also Read: Trump Tariffs Spare Drugmakers But Threaten Diabetes Device IndustryNew with Dexcom G7 15 DayLongest lasting CGM system wit ...

What should investors do during a market downturn? Some might resort to panic selling, but that's hardly a good strategy. Unless a company's investment thesis has changed because of recent developments, market downturns aren't a good enough reason for most investors to sell.For those who can afford it without blowing their budget, it's actually a great idea to pick up shares of top companies on the dip during a correction. With that in mind, here are two excellent growth-oriented companies to buy in the ong ...

DexCom (DXCM) recently signed a licensing and data partnership with a privately held healthcare-at-home digital diagnostics company — Nanowear. Per the terms of the agreement, Nanowear will use glucose data from Dexcom G7 Continuous Glucose Monitoring Systems (CGM) synchronously alongside Nanowear's previously FDA-cleared cardiovascular biomarkers for investigational purposes. With this recent deal, DexCom continues to strengthen its leadership in CGM integration. This collaboration also aligns with the com ...

Core Viewpoint - DexCom (DXCM) is under regulatory scrutiny from the FDA due to a warning letter that may impact the approval of its upcoming 15-day G7 continuous glucose monitor (CGM) [1][2][10] Regulatory Concerns - The FDA's warning letter highlighted multiple violations, including the failure to submit a premarket notification for significant modifications to its sensors, which poses increased risks for users [1][2] - Concerns were raised regarding Dexcom's testing procedures for glucose and acetaminophen concentrations in both G6 and G7 CGMs, as well as issues related to dissolved oxygen content values in G6 sensors [2] Market Impact - Following the warning letter, DXCM shares fell by 1.9% on March 25, with a year-to-date decline of 7.2%, compared to a 2% decline in the industry and a 2.1% decrease in the S&P 500 Index [3] - A potential delay in obtaining clearance for the G7 sensor could result in a loss of market share, especially against competitors like Abbott's Libre, which has a longer wearable life [4] Sales and Distribution - Although the warning letter does not mandate an immediate recall, it may cause delays in regulatory approvals, and the company has halted commercial distribution of G7 with faulty sensors, potentially impacting first-quarter sales [5][6] Company Response - Dexcom has reaffirmed its commitment to regulatory standards and is working with the FDA to resolve issues, although the FDA has deemed the company's response as inadequate [9] - Despite the regulatory challenges, Dexcom remains confident that the warning letter will not materially affect the approval or launch of the 15-day G7 CGM, expected in the second half of the year [10]

Core Insights - DexCom, Inc. has introduced new data for its G7 15-day continuous glucose monitoring (CGM) sensor, showcasing a mean absolute relative difference (MARD) of 8.0%, positioning it as the most accurate CGM in the market [1] - The G7 sensor's extended wear time and enhanced connectivity are expected to revolutionize diabetes management, particularly for Type 2 diabetes patients [3][4] - The company anticipates FDA approval for the G7 sensor by the second quarter of 2025, with a potential launch in the latter half of the year [5] Product Features and Market Position - The G7 sensor offers a 15-day wear duration, an improvement over the previous 10-day version, which reduces replacement frequency and overall costs for users [4] - DexCom is recognized as the most connected CGM brand globally, with new integration capabilities for devices like Omnipod 5 and NovoPen [10] - The company is leading the CGM market by driving innovation, expanding insurance coverage, and advocating for broader access to diabetes technology [3] Industry Trends and Healthcare Professional Insights - A survey indicates that 52% of healthcare professionals believe CGMs and diabetes education will be more crucial than new medications in managing Type 2 diabetes over the next decade [6] - There is strong support among healthcare professionals for CGM access among insulin users, with 96% advocating for multiple daily insulin injection users to have access [7] - Despite increasing recognition of CGMs, challenges such as funding constraints and restrictive eligibility criteria remain [8] Insurance Coverage and Accessibility - Insurance coverage for CGMs in the U.S. is improving, especially for intensive insulin users, with private insurers beginning to extend coverage to non-insulin users [9] - Medicare currently restricts CGM coverage to insulin users, but advocacy efforts may lead to policy changes in the future [9]

Core Viewpoint - DexCom received a warning letter from the FDA due to deficiencies in manufacturing processes and quality management systems, but it does not restrict the company's operations or require product recalls [1][2] Regulatory Actions - DexCom is committed to corrective measures and continuous updates to the FDA, asserting no material impact from the warning letter and that production and distribution remain unaffected [2] - Further regulatory actions could exacerbate existing supply-chain issues, as DexCom has faced challenges related to inventory management and manufacturing disruptions [3] Competition Landscape - DexCom's market share in the durable medical equipment (DME) channel is expected to remain stable, but rising competition from larger rivals like Abbott and Roche poses a concern [4] - Abbott's FreeStyle Libre CGM system has seen significant growth, with sales exceeding $1.8 billion in Q4 2024, a 22.7% increase year-over-year, and projected annual sales of $10 billion by 2028 [5] - Roche's Accu-Chek SmartGuide, recently receiving CE Mark approval, offers advanced features and is set to launch in select European countries [6] Analyst Perspectives - Analysts expect minimal long-term impact from the FDA warning, referencing iRhythm Technologies as a precedent for minimal disruption after similar warnings [7] - DexCom's revenue guidance for 2025 is projected at $4.6 billion, an increase from $4 billion in 2024, with additional remediation costs anticipated but not expected to significantly impact margins [7] Market Position - DexCom holds approximately 74% of the U.S. CGM market share and has strengthened its position through strategic initiatives, including FDA approval of the first over-the-counter CGM in March 2024 [8] - The company has invested $75 million in smart-ring technology to integrate CGM with wearable health technology, reinforcing its long-term growth strategy [8]

Raymond James Institutional Investors Conference 2 Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "targets," "guidance," "expects," "intends," "may," "plans," "potential," "predicts," "prospects," "projects," "should," "will," "would" or similar expressions and the negatives of those terms, although not all forward-looking statements contain these identifying words. Forward-looki ...

Company Overview - DexCom, Inc. is focused on continuous glucose monitoring for diabetes management, emphasizing its personal mission to address the health crisis associated with diabetes [3][4]. Industry Context - Diabetes is recognized as an escalating health and economic crisis, impacting many individuals and families, highlighting the importance of effective therapies and monitoring solutions [5].