Due to a shortage of radiologists and other imaging specialists, AI-enabled technologies are of significant interest—and hold ...

The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare ...

Ultimately our certification journey drove innovation and inserted even more rigor into our product development process.

The Home as a Health Care Hub will bring together patients, providers and device developers with the goal of making health ...

Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, ...

Typically, costs are reduced by using less material and floor space, and eliminating any specialty equipment required for handling large or heavy parts. For miniature devices, the equation is reversed ...

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and ...