Global Executive Summary: U.S. Food and Drug Administration (FDA) 510(k) clearance has been officially granted for the Felix NeuroAI™ Wristband. Powered by advanced closed-loop bioelectronic artificial intelligence, Felix is a noninvasive, drug-free therapeutic wearable engineered to treat upper limb tremor in adults with Essential Tremor (ET). Medical device importers, hospital procurement officers, and movement disorder clinics can now evaluate this regulatory-approved breakthrough for regional distribution.
Transforming Essential Tremor Care with AI Therapeutics
Fasikl Inc., a pioneer in bioelectronic medicine and neuro-artificial intelligence, has reached a key milestone with U.S. FDA 510(k) clearance for its proprietary Felix NeuroAI™ Wristband. Essential Tremor affects over 7 million individuals in the United States and tens of millions globally — occurring at roughly seven times the prevalence of Parkinson’s disease. The disorder causes involuntary, rhythmic shaking during movement, severely impairing everyday functional tasks such as eating, drinking, writing, and using tools.
For international healthcare providers and hospital purchasers, traditional ET options present clear clinical drawbacks. Oral pharmaceuticals (e.g., beta-blockers, primidone) deliver inconsistent benefit to less than 50% of patients and are frequently limited by systemic side effects. Surgical modalities — including Deep Brain Stimulation (DBS) and Transcranial Focused Ultrasound (MRgFUS) — achieve clinical efficacy but carry high invasive risks, elevated cost, and restricted patient eligibility. Felix introduces a scalable, 100% noninvasive prescription alternative.
The TRANQUIL Pivotal Clinical Trial
FDA clearance was backed by robust data from the TRANQUIL study, a prospective, randomized, double-blind, sham-controlled multi-center trial. The study evaluated functional upper limb tremor reduction and daily living performance against placebo devices.
- Statistically Superior Efficacy: Met primary endpoints, demonstrating significant hand tremor reduction over sham controls.
- Functional Improvement: Clinically meaningful gains in patient ability to perform activities of daily living (ADLs).
- High Safety Profile: Zero serious device-related adverse events recorded across all patient cohorts.
- Consistent Across Demographics: Reliable efficacy demonstrated regardless of age or disease duration.
"The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor," stated Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology and Director of the Movement Disorder Program at The University of Kansas Health System. "For many patients, pharmaceuticals fall short and surgery carries inherent risk. An AI-powered wearable backed by gold-standard clinical evidence provides an invaluable noninvasive option."
Felix NeuroAI™ System Overview for Healthcare Buyers
The Felix platform integrates high-precision hardware with cloud-based neural models to create a closed-loop therapeutic ecosystem.
Regulatory Status
U.S. FDA 510(k) Cleared (Prescription Wearable Medical Device).
Target Indication
Symptomatic relief of upper limb tremor in adult Essential Tremor patients.
Core Technology
Closed-loop biosignal decoding & dynamic peripheral nerve stimulation.
AI Calibration
Continuous cloud model updates tailored to individual patient neural signatures.
Global Distribution & Hospital Partnership Opportunities
Fasikl is executing a multi-phase rollout strategy. Following initial prescription availability in key U.S. clinical networks, global market expansion and hospital supply agreements are actively underway.
International medical device distributors, neurological clinic networks, and health system procurement directors are invited to partner with Fasikl for regional registration, trial deployments, and commercial distribution agreements.
Partner with Fasikl for Neuro-AI Technology
Connect directly with our commercialization team to request technical dossiers, clinical trial reports, or regional distribution terms.