VasoSeal ES Website Understates Complication Rate, FDA Warning Says
This article was originally published in The Gray Sheet
Executive Summary
Datascope's website for its VasoSeal ES vascular hemostasis device indicates a lower complication rate than approved labeling for the device, FDA maintains in a July 24 warning letter. "The actual major complication rates are substantially higher than what is claimed," FDA says.
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Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.