Workers at a medical device warehouse in Georgia have filed a lawsuit against Sterigenics and ConMed, saying they were unwittingly exposed to high levels of a toxic, cancer-causing gas.…
A class action lawsuit calls for Braun Medical to provide medical monitoring and compensation for those living around its Allentown facility, indicating that residents and workers were exposed to high levels of cancer-causing ethyline oxide gas leaks.…
The FDA is holding a public hearing on April 1 to discuss potential ways it can improve medical device safety warnings and recalls.…
The FDA warns that the closure of a number of medical device sterilization facilities may lead to critical shortages and urges manufacturers to warn them of problems as early as possible.…
Patient deaths may often go unreported or misclassified in FDA medical device reports, according to the findings of a new study.…
The FDA will hold an advisory committee meeting in November focusing on the safety of metal used in medical implants.…
The FDA has issued several new guidelines for mobile apps which will help determine which require federal oversight and which may not.…
Georgia officials are investigating a potential toxic gas release from a Sterigenics plant near Atlanta following a number of lawsuits over similar problems in Illinois.…
Dozens of lawsuits against Sterigenics claims the medical device sterilization facility released highly carcinogenic chemicals into the air, causing numerous illnesses and cancer.…
The FDA has issued a draft guidance on how to determine what medical devices can enter an MRI machine safely.…
