The US Food and Drug Administration (FDA) has approved the Felix NeuroAI Wristband developed by Fasikl, providing a new artificial intelligence (AI)-driven solution for adults with essential tremor.
The condition, which affects an estimated seven million Americans, is characterised by involuntary and rhythmic shaking, primarily in the hands. It is notably more prevalent than Parkinson’s disease.
According to Fasikl, traditional approaches to managing essential tremor often include medication or surgical procedures like deep brain stimulation, both of which present certain limitations and risks. Medications can lead to inconsistent results and undesirable side effects, while surgery is invasive and may not suit all patients, especially older individuals or those with additional health concerns.
In contrast, the Felix NeuroAI Wristband offers a noninvasive alternative, said the company.
The device integrates with Fasikl’s cloud-based AI platform to deliver continuous, personalised therapy through brain-AI co-adaptation. Worn on the wrist, it adjusts stimulation dynamically to provide all-day relief from symptoms and is designed to fit seamlessly into users’ daily routines.
Fasikl CEO Zhi Yang said: “FDA clearance of Felix marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies.
“This breakthrough in noninvasive, intelligent, and personalised neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable.”
The FDA’s clearance followed findings from the TRANQUIL study—a randomised, double-blind, sham-controlled trial that achieved its primary endpoint.
The study demonstrated that the wristband significantly reduced tremors and improved patients’ ability to perform everyday tasks compared to a placebo device.
It confirmed the device’s efficacy across various demographics without serious adverse events.
Fasikl, headquartered in Minneapolis and originating from a 2019 spin-off from the University of Minnesota, focuses on developing AI-powered neural technologies. Its proprietary platform captures neural signals from peripheral nerves to enable adaptive therapy for neurological conditions.
The company aims to transform treatment for movement disorders and other neurological impairments through its innovations like the Felix NeuroAI Wristband and the experimental Fasikl-X Nerve-Computer Interface.
The Felix NeuroAI Wristband is set to become available by prescription in select US regions starting this year, with plans for nationwide distribution in 2026.
