International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Device companies invited to get involved in EU health technology assessment process. Concepts behind the European Commission's upcoming device regulatory reform proposal. More international news.
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Smith & Nephew Withdraws Metal Hip Liners
The firm is discontinuing sales of an optional metal liner for one of its hip systems due to higher-than-expected revision rates.
U.K. Health Dept. Recommends Stronger Adverse Event Reporting System In Wake Of Breast Implant Scandal
Internal review finds U.K. regulators were not at fault in the PIP breast implant scandal, but recommends improvements to adverse event reporting and analysis.
The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.