Patients are suing medical device makers for selling spinal cord stimulators to treat chronic back pain but allegedly triggered worsening pain and electric shocks. The complaints, however, will face a ...
Medtronic has secured FDA approval for its first closed-loop spinal cord stimulator, designed to take in signals from the body and adjust its therapy automatically. The Inceptiv implant for chronic ...
The suits cite the U.S. Supreme Court’s 2024 decision in Loper Bright Enterprises v. Rainmondo in naming the FDA as a defendant. The lawsuits allege the devices should require pre-market approval ...
Inceptiv is a small device, implanted in the lower torso with leads to the spinal cord, that provides responsive counter-stimulation to relieve chronic pain. The device was approved by the FDA in ...
The new labeling will include outcomes from a study showing “superior back pain relief” compared to conventional spinal cord stimulation, according to a March 17 news release. Eighty-four percent of ...