The FDA is set to exempt certain types of software from regulatory oversight as it reconsiders its approach to products on the fringes of the medical device sector. Officials at the agency set out ...

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical ...

Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of ...

The Food and Drug Administration Tuesday issued a final rule that updates the definition of a custom device to include new statutory requirements and procedures. Under the provision, custom medical ...