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...

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