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 ...

Abbott, Dexcom, Insulet, Medtronic and others are developing next-gen sensors, pumps and algorithms for type 2 diabetes ...

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

Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.

The FDA has cleared Dexcom’s Stelo as the first continuous glucose monitoring (CGM) device that does not need ... for one two-week sensor and £300 for four. There are more than 25 million ...

Jayson Bedford, a senior analyst at Raymond James, wrote in a March 9 research note that Dexcom said the sensors are performing as expected; the issues observed by the FDA do not impact the end ...

AI-enhanced glucose monitoring provides predictive analytics and personalized insights for better blood sugar management.

At the conference, first-ever accuracy and performance data will be presented for Dexcom’s upcoming G7 15 Day system,1 showing an overall mean absolute relative difference (MARD) of 8.0%, making ...

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 ...