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As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More
A Texas jury has ordered Johnson & Johnson to pay $1.2 million to a woman who alleged that a vaginal mesh implant used to treat incontinence eroded inside her, causing pelvic pain. Read More
Hospira will pay $60 million to settle a class-action lawsuit that claimed the company misled investors about its quality problems, under a plan tentatively approved in federal court. Read More
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related analysis off the market. Read More
A new FDA report shows medical device recalls nearly doubled from fiscal year 2003 to 2013, but a greater focus on safety — not shoddier products — appears to be behind the rise. Read More
HHS’ health IT coordinator is calling for all electronic health records to incorporate the unique device identifiers of implantable devices by 2015. Read More
Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More
Some devicemakers preparing for the European Commission’s regulation on restricting hazardous substances (RoHS 2), which comes into effect in July, are feeling a financial squeeze from its requirements. Read More