July 1, 2025 — Minneapolis—Fasikl, a pioneering neuro-AI company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first-of-its-kind Felix™ NeuroAI™ Wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor.
This marks a global milestone: Felix is the world’s first and only FDA-approved AI-powered medical device for treating movement disorders, defining a new era of AI therapeutics — an alternative to medication, surgery, and traditional medical devices.
Source：https://www.fasikl.com/
Tigermed-Jyton, a subsidiary of Tigermed and a leading medical device CRO, supported the pivotal clinical trial — a high-standard, multi-regional study conducted across 12 hospitals, including 8 in the United States and 4 in China.
About Essential Tremor
Essential tremor (ET) is a common neurological disorder affecting 7 million people in the U.S. and over 10 million people in China1. It causes involuntary, rhythmic shaking, primarily in the hands, disrupting daily tasks and quality of life 2,3.
Current treatments, including medication and surgery, have limitations. Medications often produce inconsistent results and side effects, while surgical options like deep brain stimulation carry risks and are not suitable for all patients4. There remains an urgent need for more effective, safer, and scalable therapies.
Felix™ NeuroAI™ Wristband — The World’s First AI Therapeutic
Felix offers a non-invasive, drug-free, and personalized treatment powered by Fasikl’s cutting-edge AI technology. Worn on the wrist, the device connects to the cloud, where AI continuously adjusts stimulation parameters to deliver dynamic, personalized therapy that calms tremors and restores motor control. This pioneering approach brings AI directly into disease treatment - a milestone in the evolution of AI in healthcare5.
Clinical data show that Felix™ delivers all-day relief for both hands and is effective across mild to severe tremor cases. It can be used on its own or alongside medication, providing a flexible, patient-friendly solution5.
FDA clearance was granted based on compelling results from the TRANQUIL study — a randomized, double-blind, sham-controlled trial. Patients in the treatment group showed statistically significant improvements over the placebo group, as measured by both the primary endpoint and multiple secondary endpoints6.
The TRANQUIL study findings were presented as a Late-breaking Science highlight at the 2025 American Academy of Neurology Annual Meeting.
Tigermed-Jyton: A Global CRO Partner for Medical Device
Tigermed-Jyton served as the sole CRO for the TRANQUIL study. Multi-regional clinical trials are widely recognized as challenging for both the sponsor and the CRO, but Tigermed-Jyton’s deep expertise and cross-border team ensured the trial was well-coordinated and completed on time.
In addition to managing the complexities of the clinical trial itself, Tigermed-Jyton also supported the FDA submission, providing timely and effective responses to regulatory queries, helping keep the project on schedule and the approval process smooth.
Mr. Zhi Yang, CEO of Fasikl, commented:
“To rigorously evaluate Felix’s efficacy and safety as the first AI therapeutic, we chose to conduct a double-blind, randomized, sham-controlled study — the gold standard for assessing a therapy. Opting for a multi-regional clinical trial raised the bar even higher; if successful, it would set a benchmark for how future AI therapeutics should be evaluated and what standards to expect. Tigermed-Jyton is among the few CROs capable of coordinating such a complex and ambitious study. We are grateful for their support in our trial and deeply impressed by their outstanding service.”
Yifei Peng, General Manager of Tigermed-Jyton, stated:
“Congratulations to Fasikl on this remarkable achievement. The approval of Felix™ highlights how AI can shape neurological care. We’re proud to have supported every step of development, from trial launch to regulatory success. This outcome reflects Fasikl’s innovation and the Tigermed team’s professionalism and dedication.”
The Felix™ NeuroAI™ Wristband will be available by prescription through selected U.S. healthcare providers starting in 2025, with nationwide rollout planned for 2026.
About Fasikl
Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl’s portfolio includes the FDA-cleared Felix™ NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface.
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Reference:
1. Louis ED, Ottman R, How Many People in the USA Have Essential Tremor? Deriving a Population Estimate Based on Epidemiological Data, Tremor and Other Hyperkinet Mov.2014; 4.
2. Zesiewics, TA, et al., Practice Parameter:Therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology, Neurology.2005; 64(12):2008-2020.
3. 3. Louis ED, Machado, DG, Tremor-Related Quality of Life:A Comparison of Essential Tremor vs. Parkinson’s Disease Patients, Parkinsonism Relat Disord.2015; 21(7):729-735.
4 Diaz, N. L., & Louis, E. D. (2010). Survey of medication usage patterns among essential tremor patients: movement disorder specialists vs. general neurologists. Parkinsonism & related disorders, 16(9), 604-607. https://doi.org/10.1016/j.parkreldis.2010.07.011
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