USA -
Will a new FDA user fee discourage innovation in medical devices ?

More medical device companies have been using an alternative pathway to get innovative products on the market faster, but a new user fee on industry could affect the use of this pathway.

The “de novo” classification pathway has been used to get devices on the U.S. market such as Accelerate Diagnostics Inc.'s PhenoTest BC Kit, the first test to identify organisms that cause bloodstream infections and provide information on the correct antibiotics for treatment. De novo is a way to get products on the market without going through the Food and Drug Administration’s most stringent review process, known as premarket approval.

However, if companies have to pay a new fee that is seen as relatively burdensome, it could dissuade applicants from seeking de novo classification...

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Germany -
German court rejects compensation claim over faulty breast implants

Germany's federal supreme court said on Thursday it had rejected a woman's claim for certification agency TÜV Rheinland to pay compensation for approving faulty breast implants produced by manufacturer PIP until its 2010 closure. Poly Implant Prothèse (PIP), the French company at the center of the scandal, sold implants globally over almost two decades until investigators discovered it was passing off low-grade industrial silicone as a much pricier medical product. The counterfeit substance was used in implants given to some 300,000 women. About one-quarter of those subsequently removed were...

Worldwide -
Will Theranos Settle Walgreens Feud for Less Than $30M?

The embattled startup continues to chip away at heaps of litigation while focusing its business efforts on developing and selling a tabletop blood-testing device. Theranos promised to "vigorously" defend itself against Walgreens , and it appears the embattled blood testing company and its lawyers have done a surprisingly decent job of it. The Wall Street Journal ( WSJ ) reported Wednesday that Theranos and Walgreens reached a tentative settlement in which Theranos would pay the drugstore company less than $30 million. That’s a pretty good deal for Theranos, considering Walgreens had...

International -
5 secrets of contract manufacturing longevity

Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets...

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