A class action lawsuit against a British device maker claims that thousands of patients were exposed to a potentially fatal infection through an open-heart surgery device. The lack of timely tracking ...

Successful new medical devices hinge on the designer’s understanding of the specific requirements of the procedures they support, including factors like usage frequency and duration. This is ...

A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

A managed care lobbying group is calling for tighter controls over the approval, monitoring and maintenance of reusable medical devices, according to news reports. The Wall Street Journal recently ...