"Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and ...

The app highlights the importance of Software as a Medical Device (SaMD ... and the shift toward preventive care. Smartphones can reduce dependency on expensive monitoring wearables, breaking ...

“Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them ...

According to the CDC, more than 38 million Americans have diabetes. This warning is for people who use diabetes apps like ...

The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...

The US FDA warns users of smartphone-linked diabetes devices like CGMs and insulin pumps of potential health risks due to ...

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

The agency mostly enforces safety requirements on apps that turn smartphones into the equivalent of devices, for example, by ...

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible ...