Medical device distributor Jet Medical and two related companies agreed to pay $745,000 in a Federal Food, Drug and Cosmetic Act infringement case involving migraine headache devices not approved by the FDA.
The settlement includes $200,000 from Jet Medical for criminal allegations and the remaining balance from all three companies for civil allegations, according to a Jan. 4 news release from the Justice Department. The case accuses Jet Medical of distributing the Allevio SPG Nerve Block Catheter — a device marketed as a migraine treatment and sold from 2014 through 2019 — which never gained the OK from regulators and was never tested for its safety and effectiveness.
Medical Components and Martech Medical Products are the two companies involved in the civil case. The two companies and Jet Medical allegedly "instructed, coached and encouraged medical providers to submit improper billing codes to Medicare for reimbursement of services using the Allevio device," according to the release.