A Medical Device Daily
AtriCure (West Chester, Ohio) reported that it received a letter on Oct. 27 from the U.S. Department of Justice-Civil Division (DoJ) informing the company that the DoJ is conducting an investigation for potential False Claims Act and common law violations relating to the company's surgical ablation devices.
Specifically, the letter states that the DoJ is investigating the company's marketing practices utilized in connection with its surgical ablation system to treat atrial fibrillation (Afib), a specific use outside the FDA's 510(k) clearance.
The letter also states that the DoJ is investigating whether AtriCure instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes.
The company said it understands that the DoJ is in the process of compiling a document request and added that it intends to cooperate with the DoJ in its investigation and operate its business in the ordinary course during the investigation.
AtriCure develops cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac tissue.
In other legalities, Immersion Medical (San Jose, California), a developer and licensor of touch feedback technology, reported that the U.S. District Court for the Eastern District of Texas has set a scheduling conference for Dec. 2 concerning Immersion's patent infringement lawsuit against Mentice AB, Mentice SA (both Gothenburg, Sweden), Simbionix USA (Cleveland) and Simbionix Ltd. (Israel).
It is anticipated that the court will set a trial date during that meeting.