medical device

WASHINGTON (AP) -- The government should abandon a 35-year-old system for approving most medical devices in the U.S. because it offers little to no assurance of safety for patients, a panel of medical experts concludes in a report Friday....

WASHINGTON (AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates....

WASHINGTON (AP) -- Drug and medical device firm Abbott Laboratories said Friday it has abandoned plans to sell its vaccines unit, less than three months after exploring sales talks with rival companies....

WASHINGTON (AP) -- Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year....

CHICAGO -- More than 70,000 children and teens go to the emergency room each year for injuries and complications from medical devices, and contact lenses are the leading culprit, the first detailed national estimate suggests.

A tiny new medical clip - like the one implanted in Elizabeth Taylor's ticker - might save millions of Americans from open-heart surgery, doctors said Sunday.

WASHINGTON (MedPage Today) -- The FDA cautioned that postapproval changes made to a low-heat medical device sterilizer pose a safety threat to patients and healthcare workers alike.

Everyone with high blood pressure (AP) -- some 72 million Americans - should own a home monitor and do regular pressure checks, the American Heart Association and other groups urged Thursday in an unprecedented endorsement of a medical device for consumers....