The hat’s electrodes are attached to a machine that delivers a low-level electrical current to the scalp of patients with gliobastoma multiforme (GBM) tumors. The electricity disturbs the shape of the tumor cells to the point where their growth is either stopped or in some cases, reversed.
According to the National Cancer Institute, approximately 19,000 people in the United States are diagnosed with primary brain cancers each year.
A GBM tumor is highly resistant to standard cancer treatments like surgery, radiation and chemotherapy, according to an FDA press release.
"Recurrent glioblastoma multiforme is a devastating form of brain cancer that often eludes standard treatments," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in the press release. "The agency's approval of the NovoTTF-100A System shows the FDA's commitment to innovative new devices that provide patients with other treatment options."
A patient who wears this device will not face nausea and fatigue, two typical side effects of chemotherapy.
Developed by NovoCure, a privately held company in Portsmouth, New Hampshire, the hat can be plugged into a wall outlet or powered by a battery.