Advanced Bionics LLC, a Valencia, California-based manufacturer of cochlear implant system devices, has agreed to pay more than $12 million to resolve allegations that it misled federal health care programs regarding the radio-frequency (RF) emissions generated by some of its cochlear implant processors.
“The United States expects device manufacturers to provide accurate information when they claim that their devices meet certain tests or standards,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice’s Civil Division. “The integrity of our health care system depends on the government being able to rely on the information provided by manufacturers when they apply for permission to market their devices.”
“The FDA’s approval process requires companies to demonstrate the efficacy of their products,” said U.S Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “The settlement in this case demonstrates our commitment to hold responsible any medical device manufacturer that skirts these rules and seeks FDA approval of a device it knows is not as effective as represented. The consumers who use these devices, and the federal programs that pay for many of them, deserve better.”
The tests at issue measured the extent to which cochlear implant systems generate RF emissions that can potentially interfere with other devices that use the RF spectrum. Such other devices may include telephones, alarm and security...
Over the last year, beyond traditional healthcare and federal procurement matters, the government has pursued federal False Claims Act (FCA) investigations and enforcement across high-risk areas, i...