Cardiovascular Research Technologies Meeting In Brief
This article was originally published in The Gray Sheet
Abbott’s drug-eluting stent pipeline
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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.
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.