Sterigenics Lawsuit Goes Before Jury Over Medical Sterilization Plant Pollution
The first Sterigenics lawsuit over ethylene oxide releases has begun in an Illinois court.
Tag Archives: Medical Device
-
-
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.
-
FDA Issues New Draft Guidance on How Medical Device Manufacturers Should Warn of Potential Shortages
The FDA has proposed a new draft guidance outlining what manufacturers should do when they become aware of a potential medical device shortage during a public health emergency.
-
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.
-
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,…
-
FDA Safety Inspections Falling Further Behind Due To COVID-19 Pandemic, GAO Report Warns
While federal regulatory agencies continue to limit travel during the COVID-19 pandemic, a new government watchdog report warns that the U.S. Food and Drug Administration (FDA) has fallen even further…
-
Pulse Oximeters Less Accurate When Used On Dark-Skinned People of Color, FDA Warns
The FDA warns that pulse oximeters may be more inaccurate when used on people of darker skin.
-
Patients With AFX Endovascular Grafts Should Get Annual Checkups For Endoleaks: FDA
The FDA warns patients who received Endologix AFX Endovascular graft systems follow up with their doctor annually due to the risk of endoleaks which could cause health complications.
-
Medical Device Safety Warnings To Be Subject of FDA Virtual Public Meeting
The FDA plans to hold a virtual meeting in November to discuss with the public ways to improve its medical device safety warnings.
-
Water Circulating Hot/Cold Therapy Problems Result in FDA Warning Over Injury Risk
The FDA warns of potential injuries from hot and cold therapy devices if instructions are not closely followed.