September 13, 2019

Medical device manufacturer Avalign Technologies, Inc. and its subsidiary Instrumed International, Inc., will pay $9.5 million to resolve allegations that the companies unlawfully marketed devices not properly approved by the FDA for use in spinal surgeries, circumcisions, and other medical procedures, with knowledge that the devices did not have the required FDA approvals.  The allegations were originally made in False Claims Act action brought by a whistleblower.  USAO SDNY

Tagged in: FCA Federal, Healthcare Fraud, Medical Devices and DME, Off-Label and Unapproved Use, Whistleblower Case,