News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Biocompatibles (BII.L) Pleads Guilty to Misbranding and Agrees to Pay $36 Million



11/14/2016 7:09:11 AM

  Life Sciences Jobs  
  • Newest Jobs - Last 24 Hours
  • California Jobs
  • Massachusetts Jobs
  • New Jersey Jobs
  • Maryland Jobs
  • Washington Jobs
  View More Jobs
Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said.

Under the terms of the plea agreement before the US District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in connection with the company’s misbranding of the device, known as LC Bead, in violation of the Federal Food, Drug and Cosmetic Act.

LC Bead was initially approved by the US Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations, but the device has never been cleared as a drug-device combination product or for use as a drug-delivery device or “drug-eluting” bead.

Read at News Release


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES