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Abbott Laboratories Inc.

www.abbott.com

Latest From Abbott Laboratories Inc.

Guidewire, Catheter Draft Guidance Docs Address Coating Risks

US FDA issued two draft guidelines June 14 addressing labeling and performance testing for guidewires and other interventional vascular devices. The draft recommendations address risks that have been identified in recent years resulting from the separation of coating material from the devices during deployment.

Cardiology Safety

Class I VAD Units Recalls Continue From Abbott, Medtronic

HeartMate and Medtronic’s HeartWare ventricular assist device platforms have been tagged with class I recalls in the last few weeks based on separate safety issues.

Cardiology Safety

MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms

The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.

Policy Regulation

EuroPCR 2018: Abbott's Tendyne Mitral Valve Shows Early Promise

Early data from Abbott's CE mark study of its mitral valve replacement technology Tendyne shows the device's potential in reducing mitral regurgitation in severe mitral regurgitation patients.

Cardiology Cardiovascular
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