DexCom's recent licensing deal with Nanowear is likely to reinforce the broader potential of CGMs in continuous metabolic ...
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment ...
Abbott, Dexcom, Insulet, Medtronic and others are developing next-gen sensors, pumps and algorithms for type 2 diabetes ...
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
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 ...
DexCom (NasdaqGS:DXCM) witnessed a 4% increase in its share price over the past week, as the company announced a significant integration of its G7 Continuous Glucose Monitoring Systems with Nanowear's ...
CGMs are transforming health tracking for non-diabetics, providing insights into glucose levels and influencing dietary choices and athletic performance.
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
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 ...
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...
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