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Fdanewsdevicedailybulletin

Sept. 24, 2012

Vol. 9 No. 187

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Misleading Imagery in Alzheimer’s PET Drug Lands Untitled Letter

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a web page advertisement and other promotional materials for the product, according to an FDA untitled letter. Read More

EU, Japan to Negotiate Free Trade Agreement

The European Commission is seeking the go-ahead from member states on a free trade agreement that would promote access to European medical devices in Japan. Read More

NRCC Blasts Health Law’s Tax on Medical Devices

The National Republican Congressional Committee (NRCC) is renewing its attack on the healthcare law’s 2.3 percent tax on medical devices. Read More

iPhone Attachment Designed for At-Home Diagnoses of Ear Infections

A new pediatric medical device being developed by Georgia Tech and Emory University could make life easier for every parent who has rushed to the doctor with a child screaming from an ear infection. Read More

St. Jude Medical Receives European CE Mark Approval of Eon Mini Neurostimulator

St. Jude Medical announced it has received European CE Mark approval of its Eon family of neurostimulators for patients with intractable chronic migraine. Read More

Titan Spine Receives U.S. Patent for Competitive Interbody Devices

Titan Spine announced it has been awarded a patent by the USPTO protecting the company against competitive interbody devices with a roughened surface topography, anti-expulsion edges and access to a hollow center. Read More

Smiths Medical Receives FDA Clearance for Epidural System

Smiths Medical announced that its Portex CorrectInject Safety System for administering neuraxial (spinal and epidural) medication received 510(k) clearance from the FDA. Read More

Results From Study of the MarginProbe System in Prostate Cancer Published in Nature.com

Dune Medical Devices announced results of a study published in the journal Nature.com demonstrating the utility of the MarginProbe technology in prostate cancer surgery.  Read More