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 plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly ...
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 ...
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