Expert Panel Calls For More Trials And Restricted Clinical Use In Latest Cardiology Device Opinion

A European Commission medical devices expert panel which specializes in the circulatory system has once again challenged the data that has been submitted by a manufacturer of a high-risk medical device to a notified body.

Cardiology
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The latest expert panel opinion published in the context of the Medical Device Regulation concerns an iron alloy bioresorbable stent, a class III implantable for use in newborns and infants.

The expert panel found that the evidence of the clinical benefit and the advantage over other devices is “spare” and...

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