Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Abbott, Dexcom, Insulet, Medtronic and others are developing next-gen sensors, pumps and algorithms for type 2 diabetes ...
Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.
Of the hundreds of millions of people living with diabetes, most liv. Dexcom wants to make sure they have tools to manage it.
Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...
DexCom, Inc. DXCM recently unveiled new data for its upcoming G7 15-day continuous glucose monitoring (CGM) sensor at the Advanced Technologies & Treatments for Diabetes (ATTD) conference 2025.
Dexcom’s devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors ...