FDA Finds No Risk of Death Linked to Paclitaxel-Coated Balloons and Stents
The FDA has reversed its opinion on paclitaxel-coated balloons and stents, saying they no longer believe the implants increase the risk of death for patients.
The FDA has reversed its opinion on paclitaxel-coated balloons and stents, saying they no longer believe the implants increase the risk of death for patients.
The FDA is updating warnings about problems with NuVasive Precice limb-lengthening implants following past concerns over biocompatibility.
A New York Times report warns of high rates of deformities and other side effects of the CoolSculpting fat-freezing procedure.
The FDA has issued a cybersecurity plan hopes to shore up defenses against hacking attempts aimed at hospitals and medical devices.
The first Sterigenics lawsuit over ethylene oxide releases has begun in an Illinois court.
A new study finds that many children's heart implants are approved without researchers actually knowing the effect of those devices on children's bodies.
The FDA has proposed a new draft guidance outlining what manufacturers should do when they become aware of a potential medical device shortage during a public health emergency.
The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.
Medical device manufacturers often fail to report patient deaths as deaths, distorting the FDA's view on the safety profile of those devices, which could continue to put patients at risk,…