OUS Approvals Analysis: November Product Go-Aheads Headlined by LimFlow, Abbott, Creavo
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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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.
IVD-maker biosurfit is seeking more distribution partners to roll out its new three-in-one POC HbA1c blood test across Europe. The IVD company secured CE-marking for the test to assist doctors diagnose and monitor diabetes.
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.