FDAnews Device Daily Bulletin
March 2, 2012
| Vol.
9 No.
44
Federal healthcare fraud enforcement in fiscal 2011 led to a record-breaking annual haul of about $4.1 billion, largely on False Claims Act (FCA) cases, the Justice Department and HHS say.
Abbott received a Form 483 for “deficiently written or followed” procedures for handling written and oral complaints related to its products.
Smiths Medical is recalling some models of its Level 1 Normothermic IV fluid administration sets and Hotline Blood and IV fluid warming sets after an increase in reports of disconnections of the Luer lock connector.
The FDA has reached a $1 million civil money penalty settlement with Globus Medical for the distribution of unapproved medical devices.
Health Canada issued a medical device license for the CARESTREAM DRX-Revolution Mobile X-ray System, approving its use by healthcare facilities in Canada.
A coalition of patient, consumer and public health groups urged the FDA to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.
Medical device manufacturers are feeling the effects of a sluggish economy and a revamped reimbursement model, which are leading to slow growth and record levels of mergers and acquisitions activity.
Steris has announced a collaboration with St Jude Medical that will focus on helping healthcare providers with the planning and implementation of advanced cardiac laboratories.
Former Medtronic CEO Bill Hawkins has signed on as the inaugural chairman of a new public-private partnership that aims to bring a new regulatory sciences center for medical technology to Minnesota.
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