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OUS Approvals Analysis: November Product Go-Aheads Headlined by LimFlow, Abbott, Creavo

Executive Summary

The number of medical device approvals reported outside the US rebounded in November after a very slow October. There were 14 CE marks, three approvals in Japan, and three in Canada last month, covering nine different product categories.

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To Alinity And Beyond: Abbott Dx Launches Into Its Next Phase

Abbott Laboratories' diagnostic business is rolling out its new line of Alinity systems across its core lab, point-of-care, and molecular markets. Executive VP Brian Blaser says the systems are the realization of an ongoing customer-centric shift by the business, and the firm highlights a turnaround for a diagnostics unit that, only a decade ago, Abbott was trying to wash its hands of.

Biosurfit Lands CE Mark For New Three-In-One POC HbA1c Test

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TCT 2016: Three-Year ABSORB II Data Fail To Show The Hoped-For Long-Term Benefit Of Bioresorbable Stent

The data, presented Oct. 30 at the TCT Conference in Washington, DC, also showed higher rates of device-related adverse events including myocardial infarction with Abbott’s Absorb bioresorbable stent than a metallic drug-eluting stent, but the study was not powered to show differences in clinical endpoints, so this adverse safety signal must be evaluated in future clinical trials.

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