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DOJ casts scrutiny over AtriCure business practice

This article was originally published in Clinica

Executive Summary

The US Department of Justice (DOJ) has launched an investigation into potential violations of common law and the False Claims Act by cardiac surgical ablation specialist AtriCure. The West Chester, Ohio-based firm received notification on October 27 that the DOJ was examining its marketing practices in connection with its surgical ablation system to treat atrial fibrillation, and specifically its use outside FDA 510(k) clearance guidelines. The company also said that the DOJ is also looking at “whether AtriCure instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes”. AtriCure said it intends to co-operate with the DOJ and is expecting to receive a document request from the department.

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