medtechdive10d
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 ...
thecardiologyadvisor.com9d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.
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 ...
Morningstar16d
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 ...
Monthly Prescribing Reference16d
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 ...