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 ...
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 ...
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 ...
SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities ...
We recently published a list of 10 Best Diabetes Stocks To Buy According to Billionaires. In this article, we are going to ...
Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.
Dexcom (Nadsaq:DXCM) today announced new insulin delivery integrations and updates on enhanced continuous glucose monitors ...
The FDA also cited problems with Dexcom’s handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels.
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