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Today's Issue of Medical Device Daily

Friday, October 21, 2016

Today's Headlines

FDA's Shuren expects device single audit program to soon be an official policy

MINNEAPOLIS – Full-blown device regulatory harmonization may be little more than a dream, but a convergence of sorts is still topical as indicated by remarks made by the director of FDA's device center at AdvaMed 2016. Jeff Shuren told attendees at the meeting that the medical device single audit program is not only a priority at the agency, but that it "will be an official program in the next few months."

Smaller single-port device from Fortimedix is expected to address laparoscopic barrier

A single-port laparoscopic device designed to knock down a key barrier in the space has earned a financial boost just days ahead of the product s official U.S. launch.

Alere, Abbott agree to mediation, not much else in contested merger nuptials

A court battle between Alere Inc. and its potential acquirer Abbott Labs could be inching towards a resolution. The two sides agreed last week to work with a mediator to resolve the dispute, which has landed in the Delaware Chancery Court.

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