Kirby(US:KEX) Businesswireยท2025-11-13 01:00Core 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].