medical device

The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.

Change is the only constant. A product lifecycle approach underpinned by a proactive and reactive regulatory and compliance strategy is key to success. Using digital tools to augment that process generates faster yet reliable data and results to bring safer medical devices to market that improve patient outcomes.

Tech giant Apple Corporation has recently filed a patent application for wearable devices that use novel sensors to track essential physical characteristics in humans.

A major medical device manufacturer has recalled a robotic medical surgical device due to...

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

The U.S. Food and Drug Administration (FDA) has now provided access to presentations from...

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

The U.S. Food and Drug Administration (FDA) has issued a final version of its...

The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on...

Scientists are hard at work on an implantable system that could help to detect lung cancer.