A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Nanowear, a leader in home-based cardiometabolic digital diagnostics announced that SimpleSensetm, a nanotechnology-enabled wearable, mobile and software diagnostics platform, will ingest glucose data ...
In other developments, DexCom received a warning letter from the FDA concerning manufacturing processes at its facilities in California and Arizona. Both Citi and BTIG maintained their Buy ratings ...
will ingest glucose data from Dexcom G7 Continuous Glucose Monitoring Systems (CGM) time synchronously alongside Nanowear’s previously FDA cleared cardiovascular biomarkers. The continuous ...
Carlsbad’s Ionis Pharmaceuticals struck a deal worth up to $940 million with Japan-based Ono Pharmaceutical for its medicine targeting a chronic blood disorder.
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...
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. With ...
CGMs are transforming health tracking for non-diabetics, providing insights into glucose levels and influencing dietary choices and athletic performance.