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Market & Industry Briefs

Brief summaries of recent medtech market and industry developments. This month we cover Edwards Lifescience's Sapien TAVI device, and news from emerging neurostimulation companies.

As Edwards Lifesciences Corp. moves closer to US Food and Drug Administration (FDA) approval for its Sapien Transcatheter Aortic Valve Implantation (TAVI) device, the company continues to break new ground in this arena. Late in September, the US Centers for Medicare and Medicaid Services (CMS) took the unusual step of opening a national coverage determination (NCD) analysis on Sapien, even though the device is still awaiting final FDA market approval.

According to analysts, the move by CMS is intended to ensure that appropriate use criteria is clearly laid out prior...

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