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Fdanewsdevicedailybulletin

Oct. 26, 2012

Vol. 9 No. 211

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Personalized Medicine, Big Companies to Lead MedTech Growth to 2018

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. Read More

EU Issues Draft Guidance on Marketing Authorization of Transdermal Patches

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. Read More

Panel Says Medtronic Edited Product Studies

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. Read More

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. Read More

Are Medical Devices to Blame for Rising Healthcare Costs?

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. Read More

New Standards Needed to Protect Patients From Computer Viruses in Medical Devices

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. Read More

Flaws in EU Regulation of Medical Devices, Says BMJ

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. Read More

McKesson Agrees to Buy PSS World Medical for $2.1 Billion

McKesson signed a definitive agreement to purchase supply company PSS World Medical for about $2.1 billion, including the assumption of outstanding debt. Read More