Felix NeuroAI System

by Fasikl Incorporated  · 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

Essential Tremor Therapy
The Felix NeuroAI System is an AI-powered, non-invasive wearable wristband specifically designed and FDA-cleared for the treatment of essential tremor (ET), aiming to alleviate tremor-related functional limitations in the upper limbs.
Personalized, Adaptive Stimulation
It utilizes a cloud-based AI algorithm to continuously monitor tremor patterns and adjust stimulation parameters in real-time, delivering personalized and dynamic transcutaneous peripheral nerve stimulation to the radial, median, and ulnar nerves at the wrist.
All-Day Tremor Relief
The device is intended to be worn throughout the waking day to provide continuous, all-day tremor relief and support upper limb function.
Non-Invasive Solution
Felix offers a non-invasive, drug-free alternative to surgical interventions and medications for managing essential tremor.
FDA Clearance
The Felix NeuroAI Wristband received FDA 510(k) clearance in July 2025 for its indication in essential tremor.
Mobile Notification System
The system includes a smartphone application that works in conjunction with the wristband and the cloud-based AI platform.
Physician Tip

For patients with essential tremor (ET) who have inadequate response to or cannot tolerate oral medications, or who wish to explore non-invasive alternatives to surgery, the Felix NeuroAI Wristband offers a novel, FDA-cleared, AI-powered therapeutic option. It provides personalized, all-day tremor relief through continuous peripheral nerve stimulation. Physicians should consider its potential to improve daily functional limitations and quality of life for ET patients, and note that it can be used independently or alongside medication.

The Felix NeuroAI System operates as a closed-loop system, connecting the wearable wristband to Fasikl's proprietary cloud-based AI platform. This enables continuous data integration and refinement of its algorithm to optimize treatment for each user. It also includes a smartphone application for user interaction and system control.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing — Prescription required; waitlist available; insurance/billing details provided upon reservation
DeploymentWearable device with cloud-based AI platform
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Felix NeuroAI™ Wristband received 510(k) clearance (K250096) on July 1, 2025, for tremor-related functional limitations in the upper limbs in adults with essential tremor. It is classified as an External Upper Limb Tremor Stimulator (21 CFR 882.5897).
Integrations
EHR Not specified
Specialties Neurology, Physical Medicine & Rehab

What the Web Says

The Felix NeuroAI System, developed by Fasikl, is an AI-powered platform designed to assist neurologists in diagnosing and managing neurological disorders. It aims to improve diagnostic accuracy and efficiency by analyzing patient data and providing insights. While the concept is promising, detailed reviews from physicians, healthcare IT, and major tech review sites like G2 or Capterra are not readily available in public web searches.

Overall: Mixed

Strengths

  • Aims to enhance diagnostic accuracy in neurology
  • Potential to improve efficiency for neurologists
  • Utilizes AI for data analysis and insights
  • Focuses on a critical area of healthcare (neurology)
  • Developed by Fasikl, indicating a dedicated team

Limitations

  • Limited public reviews from physicians or healthcare IT professionals
  • Lack of detailed user feedback on platforms like G2, Capterra, or Reddit
  • Specific clinical trial data and peer-reviewed studies not easily accessible publicly
  • Newer technology, so long-term efficacy and integration challenges are unknown
  • Potential for 'black box' AI concerns regarding decision-making transparency
  • Cost and implementation complexity for healthcare systems are not publicly detailed

Based on reviews from: Fasikl.com (company website), General web searches for 'Felix NeuroAI System reviews', General web searches for 'Fasikl reviews'

Last updated: 2026-07-18

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Press & Coverage

G2
The Felix NeuroAIu2122 Wristband: World's First FDA-Cleared, AI-Powered Therapeutic Device for Essential Tremor
The Felix NeuroAIu2122 Wristband, developed by Fasikl Incorporated, is the world's first FDA-cleared, AI-powered therapeutic device providing noninvasive, all-day relief for individuals with essential tremor (ET). It offers a drug-free alternative, reducing tremor-related functional limitations in the upper limbs of adults.
unknown
Essential Tremor (IETF)
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 for day-long continuous tremor relief. The device received FDA clearance in July 2025 and is available by prescription.
2026-02
Essential Tremor (IETF)
Tremor Gram u2013 March 2026
This IETF publication highlights the Felix NeuroAI system as a noninvasive, drug-free alternative for essential tremor, noting its FDA clearance in July 2025 and the company's waitlist for orders with health practitioner approval. Studies showed a 33% tremor reduction by 90 days of use.
2026-03
FDA
510(k) Premarket Notification - Felix NeuroAI System
This FDA document details the 510(k) premarket notification for the Felix NeuroAI System, submitted by Fasikl Incorporated, indicating its classification as an external upper limb tremor stimulator. The document confirms the device's FDA clearance in July 2025.
2025-11
Healthy Blue
External Upper Limb Stimulation for the Treatment of Tremors - Medical Policy
This medical policy document references the Felix NeuroAI System as one of the FDA-cleared wrist-worn devices for essential tremor, noting its transcutaneous afferent patterned stimulation (TPNS) technology. It also cites a double-blind, sham-controlled RCT showing significant ET symptom improvement for up to 90 days.
2026-05
FDA
TPLC - Total Product Life Cycle - Felix NeuroAI System (K250096)
This FDA Total Product Life Cycle entry for the Felix NeuroAI System (K250096) confirms its classification as an external upper limb tremor stimulator and lists Fasikl Incorporated as the manufacturer. It also shows MDR (Medical Device Report) events from 2021 to 2026.
2026-07

Videos

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Frequently Asked Questions

The Felix NeuroAI Wristband is a non-invasive, wearable device designed for all-day use, providing continuous, personalized tremor relief through AI-adjusted transcutaneous peripheral nerve stimulation. Physicians can prescribe it as a flexible treatment option, either independently or in conjunction with existing medications, to help manage essential tremor and improve daily function.
The Felix NeuroAI Wristband has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for tremor-related functional limitations in adults with essential tremor. Its AI algorithm solely controls stimulation and is not intended for diagnostic purposes, with no interpretable outputs, which helps define its scope of use. For specific patient data privacy protocols, physicians should consult Fasikl, the manufacturer, regarding their HIPAA or GDPR compliance measures.
The device's efficacy and safety are supported by the TRANQUIL clinical trial, a randomized, double-blind, sham-controlled study involving 125 adults, which demonstrated statistically and clinically significant improvements in modified Activities of Daily Living (mADL) scores. No serious device-related adverse events were reported, with mild skin irritation being the most common side effect.
While effective, the device showed a modest statistical benefit in clinical trials, and some patients may require weeks or months to experience the full effect. The most common adverse event reported was mild skin irritation. Physicians should counsel patients that the device aims for relief and improved function, not a cure, and that individual responses may vary.
The Felix NeuroAI Wristband offers a non-invasive, drug-free alternative to traditional treatments like oral medications, which can have inconsistent relief and side effects, and invasive surgical options such as deep brain stimulation. It can be used independently or alongside current medications, providing a flexible solution for patients whose tremors are not adequately controlled by other means. Other non-invasive devices for essential tremor also exist, such as the Motimove system and the Vilim Ball.
The Felix NeuroAI Wristband will be available by prescription, with an initial launch in select U.S. regions in 2025 and nationwide availability expected in 2026. For specific pricing details, subscription models, or associated fees, physicians should directly contact Fasikl, the manufacturer, as this information is not publicly disclosed in the available clinical summaries.

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