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Today's Issue of Medical Device Daily

Tuesday, August 30, 2016

Today's Headlines

St. Jude dubs cybersecurity allegations 'false and misleading' and MW responds

Allegations that St. Jude Medical Inc.'s (NYSE: STJ) implantable heart devices have lax cybersecurity – leaving the devices vulnerable to attacks – are "false and misleading," the company said. Analysts have sided with St. Jude on the issue, for the most part, advising that the stock's short-term sell off based on the Muddy Waters Capital LLC (MW) report was unwarranted.

To co-develop or not; FDA s latest CDx draft

The FDA guidance for companion diagnostic co-development has finally emerged in draft form, and there are a couple of interesting features about it other than that its absence may have kept a few companies on the sidelines. One of the more conspicuous things about the draft is that it suggests that the term co-development may come to mean different things to different stakeholders, not all of them particularly appetizing for industry. (MDD Perspectives)

Doggedly determined Stentys shifts from start-up mode to build on sustained growth

PARIS – The third time around proved to be the charm for Paris-based Stentys SA as it reported a 41 percent increase in sales based on what it calls a strong demand for its third-generation stent, the sixth consecutive quarter of growth.


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