The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. This dynamic which scrutinized ...

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

At the SPS 2024 event Nuremberg, Germany, ODVA announced two new updates for EtherNet/IP. The first announcement relates to the enhancement of CIP Safety on EtherNet/IP to allow for the use of ...

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...

Creating a drug that might help treat or cure a health condition in humans is a long, complex process. After developing a candidate drug that shows potential—a process that, in and of itself, can take ...

Industrial manufacturing environments have inherent risks that require vigilant machine safety measures to ensure personnel safety while protecting businesses from potential insurance increases or ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...