Former CEO Pleads Guilty to Marketing Unapproved Medical Device to Treat Migraines
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine headaches.
Mark Wright pleaded guilty in federal court to “causing the introduction of misbranded and adulterated devices into interstate commerce,” the Department of Justice (DOJ) said.
According to the DOJ, Wright also admitted that, “while FDA had recommended in April 2014 that Dolor proceed with investigational studies regarding the SphenoCath’s safety and effectiveness, Dolor never conducted any such study. Instead, Wright and Dolor continued to market the SphenoCath with the intention that it be used to treat migraine headaches by administering SPG nerve blocks.”
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