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FDA Approves Edwards' Rapid-Deployment Minimally Invasive Surgical Valve

Executive Summary

The system combines the company's proven tissue surgical valve platform with technology developed for transcatheter valves.

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Earnings Winners and Losers: JNJ, MMSI, ABT, ZBH, SNN, EW, Plus Round-Up

Among the medtech companies who have released their first-quarter 2017 sales and earnings, Johnson & Johnson and Merit Medical Systems reported progress in their long-term plans to reshape their medical device businesses, while Abbott and Zimmer Biomet received some bad news in the quarter. Smith & Nephew shows signs of a turnaround, and perennial "winner" Edwards Lifesciences provided updates on some important developments in their flagship transcatheter valve business.

US Approvals Analysis: FDA Makes Efficiency Mark For PMAs

The US agency achieved its most efficient performance in the past 15 years for original PMA submission reviews in the most recently completed application cohort. PMA approval volumes also remain healthy. Meanwhile, 510(k) review times have leveled off and clearance volumes have dropped slightly.

US Medicare Add-On Payments Granted To NuVasive, Gore

The Medicare hospital inpatient final rule gives new technology add-on payments to just two devices, Ellipse Technologies's Magec spinal bracing and distraction system, and Gore's Excluder iliac branch endoprosthesis. Two other requests were turned down, and another device was not FDA-approved in time.

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