The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

Here are 10 recent FDA decisions on new and updated drugs and medical devices. 1. FDA Approves Carestream’s Vue Motion Medical Image Viewer. The FDA approved this HTML5 web-based viewer for use on ...

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen ...

In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

Belfast-based Neurovalens has been granted medical device De Novo approval from the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for weight management. Neurovalens is ...