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Today's Issue of Medical Device Daily

Thursday, April 17, 2014

Today's Headlines

TriVascular raises $78M in below-range Wall Street debut

TriVascular Technologies (Santa Rosa, California), a company pursuing technologies to treat aortic abdominal aneurysms (AAA) raised $78 million in its Wall Street debut Wednesday on the Nasdaq Global Select Market. The company launched its initial public offering of 6.5 million shares of common stock priced at $12 a share, below the previously expected range of $13 to $15.

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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