Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical ...

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...

Smart ring market leader Oura is trying to convince U.S. lawmakers to loosen some health monitoring regulations for wearable ...

Medical device association AdvaMed has hired Melissa Torres to replace Janet Trunzo as EVP of technology and regulatory affairs.

BosSTENT is a braided stent with enhanced radiopacity, resheathability, and conformability for complex neurovascular anatomy.

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...