Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. alleging that the company made misleading statements regarding the reliability and safety of its G6 and G7 glucose monitoring devices, which were modified without FDA approval, leading to health risks for users [2][4]. Summary by Sections Lawsuit Details - The lawsuit claims that DexCom made unauthorized design changes to the G6 and G7 devices, which compromised their reliability and presented health risks to users [2]. - Allegations include overstating the enhancements and reliability of the G7, downplaying the severity of issues with the devices, and exposing the company to increased regulatory scrutiny and potential legal consequences [2]. Regulatory Concerns - On March 7, 2025, DexCom received a warning letter from the FDA regarding manufacturing and quality management issues, resulting in a share price drop of $7.12, or approximately 9.15%, from $77.84 to $70.72 [3]. - The FDA's published warning letter on March 25, 2025, confirmed that DexCom had adulterated its devices, leading to a further decline in share price by $1.77, or about 2.4%, from $75.32 to $73.55 [4]. Market Reactions - On September 8, 2025, Oppenheimer downgraded DexCom's rating to "perform" from "outperform," citing concerns over the G7's accuracy and performance, which caused a decline in share price by $2.51, or approximately 3.1%, from $80.51 to $78.00 [5]. - A report by Hunterbrook Media LLC on September 18, 2025, highlighted severe health risks associated with the G7 devices, linking them to hospitalizations and fatalities, resulting in a significant share price drop of $8.33, or about 11%, from $75.78 to $67.45 [7].

Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. alleging securities fraud due to undisclosed material design changes to its G6 and G7 glucose monitoring devices, which posed health risks to users and increased regulatory scrutiny [3][4][5]. Summary by Sections Lawsuit Details - The lawsuit covers investors who purchased DexCom securities from July 26, 2024, to September 17, 2025, claiming that the company made misleading statements regarding the reliability and safety of its devices [3]. - Allegations include unauthorized design changes to the G6 and G7 devices, which made them less reliable and posed health risks to users [3]. Regulatory Issues - On March 7, 2025, DexCom received a warning letter from the FDA regarding manufacturing and quality management concerns, leading to a share price drop of approximately 9.15% [4]. - The FDA's warning letter, published on March 25, 2025, indicated that the G6 and G7 devices were "adulterated" due to modifications made without prior approval, causing inaccuracies that could endanger users [5]. Market Reactions - Following the FDA's warning, DexCom's share price fell by $1.77, or about 2.4%, on March 25, 2025 [5]. - On September 8, 2025, Oppenheimer downgraded DexCom's rating to "perform" from "outperform," citing concerns over the G7's accuracy, which resulted in a share price decline of approximately 3.1% [6]. - A report by Hunterbrook Media on September 18, 2025, revealed severe health risks associated with the G7 devices, leading to a significant share price drop of about 11% the following day [7].