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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.
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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.
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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.
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St. Jude Medical announced it has received European CE Mark approval of its Eon family of neurostimulators for patients with intractable chronic migraine.
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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.
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Smiths Medical announced that its Portex CorrectInject Safety System for administering neuraxial (spinal and epidural) medication received 510(k) clearance from the FDA.
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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.
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