The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations in adults with essential tremor, device maker Fasikl announced.
The noninvasive, wearable peripheral nerve stimulator connects to a cloud-based AI platform and incorporates patient recordings to continuously adjust settings, allowing therapy to be personalized.
Essential tremor is one of the most common types of movement disorders, affecting approximately 7 million people in the U.S.
“For many patients, current treatment options fall short — pharmaceutical treatments are helpful for less than 50% of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention,” Rajesh Pahwa, MD, of the University of Kansas School of Medicine in Kansas City, said in a statement. “This new AI wearable wristband backed by clinical evidence is an effective treatment option in patients with essential tremor.”
The FDA’s decision was supported by the pivotal TRANQUIL trial, which demonstrated that the AI-powered wristband helped people with upper-limb essential tremor perform daily activities better than a sham device.
At 90 days, essential tremor patients randomized to the device showed more improvement in modified Activities of Daily Living scores compared with sham (P<0.0001), Pahwa reported at the American Academy of Neurology (AAN) annual meeting in April. The change in separation started after 14 days.
Improvements in clinical global impression scores were reported more frequently in the AI-powered wristband group (P=0.02). Quality-of-life activity and psychosocial scores also improved more than with sham.
The most common adverse events were mild skin irritation, which often did not require treatment. There were no serious adverse effects.
Essential tremor mainly involves the hands and arms but can affect other regions. “The pathophysiology of tremor is believed to involve a brain circuit that includes the ventral intermediate nucleus of the thalamus,” Pahwa said at the AAN meeting.
Peripheral electrical stimulation of nerves or muscles may act on the tremor network to interrupt the signaling that leads to tremor, he noted.
The wristband stimulates radial, median, and ulnar nerves. The system incorporates patient movement data and fascicle-specific neural recordings to continuously adjust settings using an AI algorithm and a smartphone app. The wristband is designed to be worn whenever a patient is awake.
The wearable will be available by prescription in 2025 in select U.S. regions and should be available nationwide in 2026, Fasikl said.
Please enable JavaScript to view the