The U.S. Food and Drug Administration (FDA) has released enforcement data from a three-year period that details trends in its inspections of medical device manufacturing plants. It shows a s... Read more
A former senior executive of Texas-based ArthroCare Corp., a publicly traded medical device company, has pleaded guilty for his role in a scheme to defraud the company’s shareholders and mem... Read more
ArthroCare Corp. has agreed to settle an investors’ class-action lawsuit for $74 million. The medical device company, which moved its headquarters to Austin from California in 2004, ha... Read more
CareFusion, a leading global medical device company, issued the following update regarding its recall of 128 EnVe™ ventilators affecting 29 customers. The FDA has classified this action as a... Read more
Federal regulators are moving to tighten their oversight of medical devices, including automated pumps that intravenously deliver drugs, food and other solutions to patients. The FDA has iss... Read more
Faulty medical devices can cause serious problems for persons receiving those devices. Complaints are surfacing about DePuy ASR hip replacement systems. DePuy Orthopaedics, an Indiana-based... Read more
A Massachusetts company is recalling tracheostomy tubes used to help patients on ventilators breathe after receiving reports that three people died while using them. The company told the FDA... Read more
Federal regulators have given medical device maker Baxter International’s recall of its dialysis machines the agency’s most urgent safety warning. The Deerfield, Illinois-based company issue... Read more
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