Device Firm To Pay Over $12 Million To Resolve Claims Related to Alleged Misrepresentations to FDA

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Device Firm To Pay Over $12 Million To Resolve Claims Related to Alleged Misrepresentations to FDA

DOJ: Cochlear Implant Maker’s PMA Applications Misrepresented Conformance With Testing Standard

Dennis Tosh

December 22, 2022 at 01:50 PM EST

A manufacturer of cochlear implant system devices has agreed to pay more than $12 million to resolve allegations originally brought by a whistleblower under the False Claims Act that the company caused the submission of false reimbursement claims to federal health care programs by misrepresenting to the FDA information about the radio frequency (RF) emissions generated by its ... Read More

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Device Firm To Pay Over $12 Million To Resolve Claims Related to Alleged Misrepresentations to FDA

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