The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...

The idea of a medical device that is fully recyclable or completely biodegradable appeals to many in the industry – even patients. Although progress has been slow, the medical device industry is ...

Thanks to AI, we’re in the midst of an unprecedented technology boom. The medical devices industry hasn’t been left out of it. Among the 10 Most Innovative Companies in the medical device field, ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

A new display prototype for high-end medical equipment employs a simple and highly resistant technology to incorporate a permanent status indicator; it serves as an additional safety feature by ...

Designers and developers of medical devices are aware of the relevance and risks involved in single faults, which must be avoided in all states of operation. However, the dynamics of development, ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...