The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

Investing.com — 周二，花旗重申了对DexCom (NASDAQ: DXCM )的买入评级和104.00美元的目标价，此举是在美国食品药品监督管理局 (FDA)公开发布警告信之后。这封最初于2025年3月4日发送的信函详细列出了去年在DexCom位于加利福尼亚州和亚利桑那州的设施检查中发现的违规行为。FDA指出，G6和G7连续血糖监测系统 ...

The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen ...

Eligible residents living with diabetes in Saskatchewan who rely on any type of insulin may be eligible to receive coverage ...

A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...

The AID system used in the study was Tandem Diabetes Care's t:slim X2 insulin pump with Control-IQ+ technology, used in conjunction with a Dexcom G6 CGM sensor that can be used with NovoLog or Humalog ...

Jaeb Center for Health Research conducted a randomized controlled trial evaluating the impact of automated insulin delivery ...

while planning to expand the production of its G6 and G7 diabetes blood sugar trackers in the greater Phoenix area. The new admonition came after the FDA found deficiencies in Dexcom’s response ...

As part of the provincial government’s recent Budget 2025 announcement, Dexcom G7 and Dexcom G6 CGM systems are now publicly covered for residents living with diabetes age 18-25 and those over ...