The FDA has approved more than a dozen neurological stimulation devices that promise to help patients with epilepsy and other neurological conditions.
But in a move that could put the devices on the market for the first time, the agency has not approved the devices for use in patients with the debilitating neurodegenerative disease amyotrophic lateral sclerosis (ALS).
As the FDA reviews the devices, it’s not clear whether the devices are safe for use by people with ALS, the American Association of Neurological Surgeons reported on Monday.
The FDA will consider whether to approve the devices and their associated documentation in the coming weeks, the AMA said.
The devices are a type of electrical stimulation device called a transcranial magnetic stimulation (TMS) that uses a magnetic field to stimulate muscles in the brain.
A device like the TMS device is known as a cathodal transcrani-magnetic stimulation device, or CT-MS, because it sends electrical pulses through the brain’s electrical fibers.
The AMA said that the FDA will require the devices to be tested for safety and effectiveness before approval, and that the agency will consider the results of the tests.
The new approvals come on the heels of FDA approval last week of two other new devices for ALS treatment: a device that uses an electrode array to deliver electrical currents to the spinal cord, and a device to stimulate muscle spindles and muscles of the arm.
While the FDA has said that it will review the applications for approval for TMS devices, a statement from the agency said the agency is “not currently evaluating the safety and efficacy of any other devices for treating neurological disorders, including amyotrophets, at this time.”
It was not clear how the new approvals would affect the companies that have developed the devices.
The company behind the devices in question is NeuroVibe, a company based in Santa Barbara, California.
The FDA’s review of the devices will be conducted in collaboration with NeuroVibes cofounder and CEO Eric Wahlberg, the statement said.
Both the FDA and NeuroVibrations are seeking regulatory approval for the devices before the devices go on the shelves in November.
The Associated Press contributed to this report.