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Today's Issue of Medical Device Daily

Saturday, April 19, 2014

Today's Headlines

NewCo on the Go: Cernostics aims to help GIs manage Barrett's patients

Gastroenterologists are usually quick to admit they do not have a good way to manage patients with Barrett's esophagus. They know Barrett's is a precursor to esophageal cancer, but they don't have a great way of predicting which Barrett's patients are likely to progress to esophageal cancer and which patients probably won't develop the cancer.

Washington Roundup: FDA data suggests fewer than a third of warning letters closed

FDA reported its warning letter close-out program in 2009 as a means of bolstering compliance, but the agency's data suggests the program has been short of a roaring success. The warning letter database shows that 935 warning letters are accompanied by close-out responses from the agency, but FDA has issued more than 2,900 warning letters between the Sept. 1, 2009, commencement of the program and Oct. 9, 2013. Using six months for the agency to issue a closeout letter yields a closeout rate of 32%, suggesting the program has not meaningfully affected compliance by regulated industries.

mHealth opportunities in Latin America on the rise

With mobile phones and tablets penetrating deeper into Latin America every year, the opportunities for mHealth developers are growing rapidly.


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