The letter also noted that the company does not monitor how acetaminophen affects glucose sensing with its G7 monitors. The FDA also said Dexcom is not properly evaluating the risk of using the G6 ...
The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the ...
The Dexcom 15-day G7 continuous glucose monitor (CGM) is accurate and safe for use up to 15.5 days in adults with diabetes. Currently under review by the US Food and Drug Administration ...
Today, the San Diego-based CGM maker announced that its G7 sensor directly connects with the NovoPen 6 and NovoPen Echo Plus in Germany. Novo Nordisk offers these smart, connected insulin pens. Dexcom ...
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 ...
Dexcom is preparing to launch a 15-day version of its G7 continuous glucose monitor, based on data presented Thursday at the Advanced Technologies & Treatments for Diabetes conference. Dexcom pointed ...
It’s a way for people to gain access to devices like the Dexcom that is intended to skip that rep tape often seen with ...
At close: March 28 at 4:00:02 PM EDT ...
Cheng Xin / Getty Images DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants. The maker of glucose monitoring devices said ...