Cos. Reach $9.5M Deal For Selling Non-FDA Cleared Devices

Law360 (September 13, 2019, 8:36 PM EDT) -- A pair of medical device companies have agreed to a $9.5 million settlement with the federal government to resolve claims that they make and sell medical devices that were not cleared by the U.S. Food and Drug Administration, the U.S. Department of Justice announced Friday.

Under the settlement, which a Manhattan federal judge has approved, Avalign Technologies Inc. and its subsidiary, Instrumed International Inc., agreed to shell out $9.5 million and admit to the government's allegations, the Justice Department said.

Manhattan U.S. Attorney Geoffrey S. Berman said in a statement that it is important that devices used in medical procedures have...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!