The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and identified concerns in manufacturing processes and quality management.

The recall affects Dexcom G6, G7, ONE, and ONE+ continuous glucose monitor receivers but not the smartphone apps or insulin ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego ...

FDA recalls Dexcom glucose monitors (G6, G7, ONE models) due to alert issues posing severe health risks. Read more here.

Dexcom is recalling certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because of a problem with the speaker that may cause it to fail to make an alert sound when blood sugar is dangero ...

The U.S. Food and Drug Administration approved DexCom, Inc.’s (NASDAQ:DXCM) Dexcom G7 15-Day Continuous Glucose Monitoring System for people over 18 with diabetes. With an overall Mean Absolute ...

Dexcom has announced it has received FDA approval of a new continuous glucose monitoring system, according to a news release. The Dexcom G4 PLATINUM system consists of three parts: a sensor, ...

FDA approves DexCom’s diabetes Android app: 3 things to know The Food and Drug Administration on Wednesday approved an Android version of Dexcom’s diabetes management mobile app.

DexCom, Inc. DXCM recently announced the FDA clearance for its 15-day wear G7 Continuous Glucose Monitoring (CGM) system, the longest-lasting and most accurate CGM approved in the United States.

FDA clears Dexcom G7 15-Day CGM for adults, offering 15.5 days of wear and a MARD of 8.0% for improved diabetes management. New features include Apple Watch connectivity, medication logging, and ...