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Edwards Lifesciences Corp.

www.edwards.com

Latest From Edwards Lifesciences Corp.

Global Approvals Analysis: Emerging Markets Drive Volume Of OUS Approvals

The numbers of medical device approvals were up in most regions outside the US and the biggest surge, by percentage, was in approvals from emerging markets and the so-called BRIC countries. It remains to be seen if the trend will continue in 2018, but many companies are already counting on important non-US approvals coming in the next year.

Approvals Innovation

Starts & Stops: 2017 Finishes With Progress For Edwards, Stalled Trials For Boston Scientific

Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve, which is currently off the market.

Clinical Trials Starts & Stops

Deals Shaping the Medical Industry, January 2018

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in December 2017.

Deals BioPharmaceutical

US FDA Pilot Program Speeds Off-The-Shelf Software Validation

The Computer System Validation pilot program is exploring ways for device manufacturers to save time in implementing new information technology tools that support quality systems and other operational functions. One strategy under review: letting companies rely on software manufacturers’ own validation for low-risk functions. Also: A quality assurance manager at device-maker Zoll Medical weighs in on his company's participation in the pilot.

Manufacturing Quality Control
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