medtechdive9d
Former FDA head Gottlieb calls for less regulation of certain AI tools
The FDA issued the final guidance in 2022, bringing several risk-scoring tools, such as software to predict the risk of ...
Hosted on MSN14d
Life-Saving Diabetes Alerts Could Be Silenced By App Glitches: How To Prevent Missing Them
The Food and Drug Administration is warning that critical alerts from diabetes devices may fail to reach users, risking severe complications or death. The FDA sent out the warning about the smartphone ...
Monthly Prescribing Reference15d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
Certain smartphone features such as battery saver, “focus mode” or “do not disturb” may change how alerts are delivered. The Food and Drug Administration (FDA) has issued a safety ...
drugdeliverybusiness13d
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical ...
Morningstar15d
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
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 ...
Yahoo Finance15d
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
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 ...