Felix NeuroAI System

by Fasikl Inc.  · Based in United States → — Creating Groundbreaking AI Therapeutics
Neurology Physical Medicine & Rehab
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Regulatory Status Disclosed

Overview

Fasikl Incorporated is a pioneering neuro-AI company, spun off from the University of Minnesota in 2019, dedicated to developing advanced, AI-powered neural technologies. The company leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. Its mission is to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations.

The Felix NeuroAI System, specifically the Felix NeuroAI™ Wristband, is Fasikl’s first FDA-cleared product. It is the world’s first AI-empowered wearable designed to alleviate tremor-related functional limitations in the upper limbs of adults with essential tremor. This non-invasive, drug-free alternative connects to Fasikl’s cloud-based AI platform, which continuously adjusts stimulation parameters to deliver personalized, dynamic therapy for all-day symptom relief. The device can be used independently or alongside medication, offering a flexible and comprehensive solution for tremor management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered neuromodulation
  • Non-invasive wearable device (wristband)
  • Cloud-based AI platform for continuous adaptation
  • Personalized, dynamic therapy
  • All-day symptom relief
  • Drug-free alternative
  • Reduces tremor-related functional limitations
  • Can be used independently or alongside medication
  • Captures neural signals from peripheral nerves
  • FDA-cleared for essential tremor

Use Cases

  • Treatment of essential tremor (upper limb functional limitations)
  • Non-invasive alternative to surgery and medication for essential tremor
  • Personalized tremor management
  • Improving daily activities for essential tremor patients

What Physicians Need to Know

Mobile Notification System
The Felix system includes a smartphone application. The device connects to the cloud, where its AI continuously adjusts stimulation parameters.
Physician Tip

The Felix NeuroAI Wristband is an FDA-cleared, AI-powered wearable device for the treatment of essential tremor (ET) in adults. It delivers transcutaneous electrical stimulation to the radial, median, and ulnar nerves at the wrist. The device uses a cloud-based AI algorithm to continuously monitor tremor frequency and amplitude, and automatically adjusts stimulation settings in real-time to optimize tremor control and provide all-day relief. Clinical trials have shown significant improvements in activities of daily living (ADL) and quality of life for patients with mild, moderate, or severe tremors. It can be used independently or alongside medication. Improvement may be seen within hours for some users, while others may require weeks or months for full effect. The device is available by prescription. Mild skin irritation was the most common device-related adverse event in clinical trials. In cases of skin irritation, switching the device to the opposite wrist has been shown to allow healing while maintaining benefit.

The Felix NeuroAI System connects to the cloud, where Fasikl's proprietary AI technology continuously adjusts stimulation parameters. It also includes a smartphone application. The device records movement signals from the patient's wrist through an inertial measurement unit with an accelerometer and gyroscope. These unique neural signals, along with multimodal physiological and real-world patient data, form the basis for disease-specific AI models that guide and adapt neuromodulation. This continuous sensing, data analysis, and adaptive stimulation create an ongoing interaction between AI and the patient's sensorimotor system.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Neurology, Physical Medicine & Rehab

What the Web Says

There is no readily available information or reviews for "Felix NeuroAI System" from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra. The product appears to be in an early stage or has a very limited public presence regarding reviews.

Overall: Mixed

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Last updated: 2026-10-30

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Press & Coverage

Business Wire
Fasikl's Felix Wristband Improves Daily and Long-Term Function for People with Essential Tremor with Ongoing Use, New One-Year Data Show
Fasikl announced that new peer-reviewed data published in Movement Disorder Clinical Practice show that patients using the Felix NeuroAI™ Wristband experienced clinically meaningful and sustained functional improvement over a full year, with greater improvement the longer they used it. The one-year open-label extension trial demonstrated growing treatment effects from ongoing use, illustrating the potential for additional benefit with long-term use of the Felix NeuroAI™ Wristband.
2026-10
fasikl.com
Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor
Fasikl announced that its pivotal TRANQUIL study met its primary endpoint, demonstrating the Felix NeuroAI™ wristband's superiority over a sham device in reducing essential tremor and improving users' ability to perform daily activities. The study results were presented at the 2025 American Academy of Neurology (AAN) annual meeting.
2025-04
NeurologyLive
Felix NeuroAI Wristband Demonstrates Superiority Over Sham Device in TRANQUIL Study for Essential Tremor
Late-breaking findings from the TRANQUIL study, presented at AAN 2025, showed that the Felix NeuroAI wristband significantly reduced essential tremor symptoms and improved daily functioning compared to a sham device. Participants using the Felix wristband experienced a mean reduction of 6.9 points in modified Activities of Daily Living (mADL) scores after 90 days of use.
2025-04
fasikl.com
Data Published in JAMA Neurology Demonstrate Fasikl's AI-Powered Wristband Improves Daily Function for People with Essential Tremor
Fasikl announced the publication of data in JAMA Neurology from a randomized clinical trial, showing clinically meaningful and statistically significant improvements in daily living and quality of life for essential tremor patients using the Felix NeuroAI™ Wristband. The article, "Transcutaneous Peripheral Nerve Stimulation for Essential Tremor: A Randomized Clinical Trial," was published in December 2025.
2025-10
American Academy of Neurology
Wrist-Worn Stimulation Device for Essential Tremor Shows Statistical Benefit Question Remain About Extent of Clinical Benefit, However
The TRANQUIL clinical trial, studying the Felix NeuroAI Wristband, found that tremor symptom reductions increased over a 90-day period, consistent with an earlier pilot trial. The FDA granted 510(k) clearance for the device based on this trial.
2026-01
essentialtremor.org
Treatment of Essential Tremor with Felix NeuroAI
Dr. Richard Dewey, medical director at Fasikl, discusses the Felix NeuroAI system, a wristband device that uses an artificial intelligence system for personalized stimulation to provide day-long continuous tremor relief. The article notes that individuals with implanted electrical devices like brain stimulators or pacemakers cannot use the device.
2026-02
FDA.gov
510(k) Premarket Notification: K250096: Felix NeuroAI System
The FDA reviewed Fasikl Incorporated's 510(k) premarket notification for the Felix NeuroAI System, an external upper limb tremor stimulator, and determined it to be substantially equivalent to predicate devices. The device is intended to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.
2025-07
FDA.gov
External Upper Limb Tremor Stimulator (Product Code QBC)
The FDA's classification for an external upper limb tremor stimulator, product code QBC, includes the Felix NeuroAI System by Fasikl Incorporated as a substantially equivalent device. This Class II prescription device is designed to aid in tremor symptom relief of the upper limb.
2026-10

Videos

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Frequently Asked Questions

The Felix NeuroAI System is an FDA-cleared, AI-powered, non-invasive wearable wristband designed to alleviate tremor-related functional limitations in adults with Essential Tremor (ET). It works by stimulating peripheral nerves in the wrist (radial, median, and ulnar nerves) to send therapeutic signals to the brain, thereby reducing tremors and restoring motor control. The system utilizes a cloud-based AI platform that continuously monitors tremor activity and adjusts stimulation parameters in real-time to provide personalized and adaptive therapy.
The Felix NeuroAI System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in July 2025 for its indication in Essential Tremor. This clearance signifies that the device is substantially equivalent to a predicate device and is safe and effective for its intended use. As a medical device, it is subject to FDA regulations including quality system regulations, labeling requirements, and medical device reporting. The company, Fasikl, also adheres to HIPAA regulations regarding the privacy and security of Protected Health Information (PHI) collected through the device and its associated app.
Traditional treatments for Essential Tremor include pharmacological options like propranolol, primidone, nadolol, topiramate, and benzodiazepines, as well as more invasive surgical interventions such as deep brain stimulation (DBS) and focused ultrasound. Other non-pharmacological, non-surgical interventions include other transcutaneous peripheral nerve stimulation (PNS) devices like Cala Trio and Motimove, orthotic/mechanical devices, cooling and vibration strategies, and adaptive utensils. The Felix NeuroAI System offers a non-invasive, drug-free alternative that bridges the gap between medication and surgery.
One known contraindication for the Felix NeuroAI System is for individuals with implanted electrical devices such as brain stimulators or pacemakers. While the device has shown significant improvements in clinical trials, some studies have noted that the numeric difference between the active device and sham treatment might not always have clinically meaningful significance for all patients. The most common device-related adverse event reported in clinical trials was mild skin irritation at the wrist. Other less common side effects have included nausea, arthralgia, worsening of prior arthritis, muscle weakness, and involuntary muscle contractions.
The Felix NeuroAI System is available by prescription through healthcare providers. Fasikl works with most major insurance providers to ensure accessibility. For eligible patients, Traditional Medicare typically covers 80% of the cost if coverage criteria are met, and a Medicare Supplement plan may cover the remaining 20%. Medicare Advantage plans generally follow traditional Medicare guidelines, with coverage and out-of-pocket costs depending on the specific plan. The device is also available through the VA health system, with coverage determined individually by each VA facility.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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