FDAnews Device Daily Bulletin
Oct. 11, 2012 | Vol. 9 No. 200
Vision care company Bausch + Lomb found cataract lens development cycles significantly reduced after engineers started first examining the way lenses would work in the eye through 3-D computer modeling, a Bausch + Lomb official says.
Reports of two serious injuries, including one fatality, prompted Stryker to issue a Class I recall of the Neptune Waste Management System.
A study in the October issue of the journal Health Affairs could fuel the debate over whether the FDA has been bringing medical devices to market in a timely manner and if the Centers for Medicare and Medicaid Services has been meeting its deadline for national coverage.
There were 113 Class I medical device recalls between 2005 and 2009, according to the Archives of Internal Medicine, meaning costly medical procedures and possible explantations for tens of thousands of patients.
Among many healthcare-related challenges facing developing countries, visual impairment remains a major issue.
Scientists have successfully tested a portable device to prepare lungs for transplant, potentially boosting the number of organs available and reducing the risk the operation will fail.
MedTech Europe, the alliance of European medical technology industry associations, launched at the European MedTech Forum in Brussels.
Covidien has received FDAO 510(k) clearance and CE Mark approval for its Nellcor bedside respiratory patient monitoring system.
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