Company Warned for Experimenting With Unapproved Device

Nebion, a California company that thought its device did not come under FDA regulation because it was being used for testing and experimentation, was forced to close late last year after it received an FDA warning letter. In its response to the agency’s Form 483 observations, Nebion claimed its experimental HLX-8 magnetic resonance device was being used on individuals who knew the testing was part of development and were fully aware that the product was not FDA approved.
Devices & Diagnostics Letter