FDAnews Device Daily Bulletin
Oct. 26, 2012 | Vol. 9 No. 211
In vitro diagnostics (IVD) could claim the lion’s share of a $440 billion global medtech market in 2018, thanks to the rise of personalized medicine, a new report by London consulting group EvaluateMedTech says.
Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.
Officials of Medtronic, the medical device maker, edited studies by outside researchers about a controversial spine treatment sold by the company, inserting claims that their product was superior to a competing one, according to a Senate Finance Committee report released Thursday.
New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines
A new white paper is available to assist medical device manufacturers with understanding recent changes to the FDA’s thinking regarding endotoxin testing.
Spending on medical devices has held steady for the past two decades as a proportion of U.S. healthcare expenditures, and the price of devices has risen slower than consumer inflation, according to a new industry-funded study.
A recent report by the U.S. Government Accountability Office found that several information security threats exist that can exploit vulnerabilities in active implantable medical devices.
A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators and breast implants.
McKesson signed a definitive agreement to purchase supply company PSS World Medical for about $2.1 billion, including the assumption of outstanding debt.
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