Cloud-AI Signal Calibration
Proprietary machine learning models process multi-channel surface neuromuscular data to capture an individual's unique tremor signature, dynamically adjusting stimulation output thousands of times per session.
Medical Technology Innovation
A Breakthrough Closed-Loop AI Neurostimulator
The Felix NeuroAI™ Wristband represents a shift in movement disorder therapy. Powered by closed-loop neural decoding algorithms and transcutaneous peripheral nerve stimulation, Felix delivers individualized, dynamically calibrated therapy to mitigate hand tremor in adults with Essential Tremor (ET).
Unlike conventional fixed-dose stimulation units or systemic pharmaceuticals, Felix connects directly to cloud neural models. It continuously analyzes neuromuscular feedback to deliver targeted modulation, establishing a noninvasive, drug-free standard of care for global healthcare providers, movement centers, and clinical distributors.
- U.S. FDA Cleared: Authorized as a prescription wearable device for Essential Tremor management.
- 100% Noninvasive Safety: No surgical implants, no brain incisions, and no pharmacologic side effects.
- Bilateral Efficacy: Clinical trials confirm single-wrist wearing relieves tremors in both hands.
Technical Capabilities
Engineering & Clinical Highlights
Built on over two decades of neural interface R&D, Felix merges real-world biosignal processing with adaptive cloud artificial intelligence.
All-Day Functional Relief
Engineered for seamless daily living, enabling users to eat, write, use tools, and perform fine motor tasks steadily throughout the workday without clinic supervision.
Non-Significant Risk (NSR) Profile
Comprehensive safety evaluations demonstrate an extremely benign safety profile, with mild skin redness being the primary observed transient reaction during rigorous 90-day clinical evaluations.
Rigorous Scientific Validation
Pivotal Trial Evidence & Peer-Reviewed Research
Fasikl adheres to rigorous evidence-based development standards. The efficacy and safety of the Felix platform are validated by double-blind clinical trials and published in tier-one medical journals.
The Pivotal TRANQUIL Clinical Trial Summary
Conducted as a randomized, double-blind, sham-controlled multicenter study, the TRANQUIL trial evaluated 90-day outcomes in Essential Tremor patients. The treatment arm demonstrated statistically significant improvements in primary endpoints (TETRAS m-ADL scores, p < 0.0001), confirming significant functional recovery across mild, moderate, and severe tremor cases.
Transcutaneous Peripheral Nerve Stimulation for Essential Tremor: A Randomized Clinical Trial
JAMA Neurology. 2025 Dec 1;82(12):1235-1242. doi:10.1001/jamaneurol.2025.3905. PMID: 41114984.
TRANQUIL: Pivotal Study of the Felix NeuroAI™ Wristband in Patients with Essential Tremor
Featured Presentation & Late-Breaking Science, 77th American Academy of Neurology (AAN) Annual Meeting.
A Pilot Study of AI-Controlled Transcutaneous Peripheral Nerve Stimulation for Essential Tremor
Tremor and Other Hyperkinetic Movements. 2025 Mar 21;15:10. doi:10.5334/tohm.991. PMID: 40125447.
Clinical Case Insights
Real-World Patient & Physician Impact
Observational evidence from clinical study participants highlights significant functional recovery and quality-of-life enhancements.
David — Active Biological Feedback
“For me, it outperforms daily pharmacotherapy. Having an AI system that actively monitors neural feedback and adjusts in real-time has not only calmed my hand tremor but restored my independence.”
Cindy — Noninvasive Alternative to Surgery
“Facing invasive deep brain stimulation surgery was daunting. Felix gave me a completely noninvasive alternative that fits my workday routine, letting me return to writing and fine motor tasks.”
Christian — Dignity & Precision Control
“Achieving surgical-grade tremor reduction without scalpel incisions or heavy sedation is remarkable. It offers a combination of clinical efficacy, dignity, and real-world mobility.”
Medical & Procurement FAQ
Frequently Asked Questions
The Felix wristband was evaluated in a prospective, randomized, double-blind, sham-controlled pivotal trial (TRANQUIL study). Unblinded data demonstrated a statistically significant reduction in hand tremor activities (TETRAS m-ADL score, p < 0.0001) compared to sham control groups.
Yes. Clinical trials verified that a substantial proportion of patients experiencing bilateral upper extremity tremor achieved bilateral relief while wearing the device on a single wrist due to central neural pathway target modulation.
Individual response times vary based on tremor etiology and severity. Many patients observe noticeable functional tremor reduction within hours of session initiation, while cumulative neural adaptation produces optimal outcomes over continuous weeks of daily therapy.
Felix is cleared by the U.S. FDA as a prescription wearable neuromodulation medical device. It holds a non-significant risk (NSR) classification, with minor, temporary skin redness underneath sensor contact sites being the main observed side effect.
Fasikl works with accredited movement disorder centers, neurological hospital networks, and international medical device importers. Contact our global procurement team to request regulatory dossiers, CE/FDA documentation, and distribution terms.