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Medical device maker settles FCA suit for $3.76 million

Atricure Inc., a medical device manufacturer, has agreed to pay the United States $3.76 million to resolve civil claims that it marketed its medical devices for uses that had not been approved by the FDA.

The Dept. of Justice had alleged that the company violated the False Claims Act by promoting its surgical ablation device to treat atrial fibrillation, a use that is not approved by the FDA. Atricure also allegedly promoted heart surgery using the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures to inflate Medicare reimbursement, and paid kickbacks to health care providers.

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