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.
Tag Archives: Medical Device
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FDA Issues Letter To Doctors About Issues with NuVasive Precice Limb-Lengthening Devices
The FDA is updating warnings about problems with NuVasive Precice limb-lengthening implants following past concerns over biocompatibility.
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FDA Warns of Cybersecurity Vulnerabilities in Certain DNA Sequencing Devices
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Coolsculpting Side Effects Cause Disfiguring PAH Complications For Some Users: Report
A New York Times report warns of high rates of deformities and other side effects of the CoolSculpting fat-freezing procedure.
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FDA Introduces Cybersecurity Modernization Plan to Prevent Hacking of Medical Devices
The FDA has issued a cybersecurity plan hopes to shore up defenses against hacking attempts aimed at hospitals and medical devices.
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Sterigenics Lawsuit Goes Before Jury Over Medical Sterilization Plant Pollution
The first Sterigenics lawsuit over ethylene oxide releases has begun in an Illinois court.
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Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study
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.
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FDA Issues New Draft Guidance on How Medical Device Manufacturers Should Warn of Potential Shortages
The FDA has proposed a new draft guidance outlining what manufacturers should do when they become aware of a potential medical device shortage during a public health emergency.
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Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns
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.
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Medical Device Deaths Likely Undercounted By FDA, Study Warns
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,…
