Life Sciences

DOJ investigating AtriCure marketing

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 17, 2008

The Department of Justice (DOJ) is investigating allegations that AtriCure, Inc., improperly marketed its surgical ablation devices for off-label uses, according to a Reuters article.

The DOJ is investigating whether the company caused false claims to be filed by promoting its devices to treat atrial fibrillation, a use not approved by the FDA. The DOJ is also looking into allegations that the company instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes.

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