The admonition came after the FDA found inadequate procedures for tracking design changes, as well as design validation and risk analyses. (Sarah Silbiger/Stringer/Getty Images) Dexcom has received a ...
Dexcom said it has received 56 reports of injuries, including seizures, loss of consciousness, vomiting and other symptoms related to hypoglycemia or hyperglycemia. The FDA listed the issue this week ...
AI can help read CGM data for glucose forecasts, but broader health profiling still faces validation, privacy, and governance ...
Hunterbrook Media released a short report on diabetes-focused DexCom Inc. (NASDAQ:DXCM), citing that the company sold the "adulterated" device. Benzinga reached out to DexCom for comments and is yet ...