The FDA has received medical device reports in which users report these alerts are not being delivered or not being heard, in cases where the users thought they had configured the alerts to be ...

The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.

The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths. The FDA issued the alert one day after BD wrote to customers ...

SILVER SPRING, Md., Feb. 5, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose ...

how often and how the alerts are delivered (e.g. audible, vibration, text only) through the app on their phone. The FDA has received medical device reports in which users report these alerts are not ...