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, ...

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 ...

Dexcom pushed back on claims in a Food and Drug Administration warning letter that the company made unauthorized changes to its glucose sensors ... major changes to its devices without submitting ...

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 ...

We recently published a list of 10 Best Diabetes Stocks To Buy According to Billionaires. In this article, we are going to take a look at where DexCom, Inc.

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 ...

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 it ...

Roche is planning to launch the device in select European countries soon. Following the receipt of the FDA letter, DexCom’s share price has been on a declining trend. However, few analysts do ...

DexCom, Inc. (NASDAQ: DXCM), a global leader in glucose biosensing, today announced the launch of its first multi-region report, the "Dexcom State of Type 2 Report: Access and Attitudes Across ...