Jet Medical, a medical device distributor, has reached an agreement to pay the U.S. government $200,000 to resolve misbranding allegations surrounding a migraine treatment, according to a Jan. 5 report from Medscape.
Jet Medical's Allevio sphenopalatine ganglion nerve block catheter was intended to treat migraines in patients. The Justice Department alleged that from April 2014 to April 2019, Jet Medical distributed Allevio without obtaining FDA approval or clearance.
The Justice Department also alleged that Jet Medical did not study Allevio's safety and effectiveness. The company admitted to distributing a misbranded device in violation of FDA compliance measures.
Jet Medical also reached a civil settlement with the federal government under the False Claims Act, and the company agreed to pay an additional $545,133.
Two of Jet's related companies, Medical Components and Martech Medical Products, are also parties in the lawsuit.
"Device manufacturers who circumvent the proper regulatory path in bringing their products to market endanger patients and put the public health at risk. We will continue to investigate and bring to justice companies that ignore the law and jeopardize the public health," Catherine Hermsen, assistant commissioner for criminal investigations at the FDA, told Medscape.