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Cardiovascular Research Technologies Meeting In Brief

This article was originally published in The Gray Sheet

Executive Summary

Abbott’s drug-eluting stent pipeline

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News In Brief

Physician sunshine rule finally released. CMS moves forward on bundled payment initiative. More news.

Abbott Sees Absorb Bioresorbable Implant As Stent Market Game Changer

Abbott will commence a 2,000-patient clinical trial by year end to support U.S. approval of its Absorb drug-eluting bioresorbable vascular scaffold as an alternative to conventional coronary stents following an initial European debut.

Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

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