The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Dexcom’s investigational 15-day continuous glucose monitor has a lower mean absolute relative difference than the current ...
DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
Insulet (Nasdaq:PODD) announced today that it made its Omnipod 5 automated insulin delivery system available in several new ...
Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.
Investors with a lot of money to spend have taken a bullish stance on DexCom (NASDAQ ... company is evolving its CGM systems to provide integration with insulin pumps from Insulet and Tandem ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...
Dexcom said the warning letter, which the FDA has yet to publish, describes non-conformities in the manufacturing processes and quality management systems at the two facilities. The company does ...