Products

Felix NeuroAI System
Fasikl Incorporated
Neurology AI
Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. Its Felix NeuroAI™ Wristband is the first FDA-cleared AI therapeutic for essential tremor, providing non-invasive, personalized neuromodulation.

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About Fasikl

Fasikl is a pioneering neuro-AI company that leverages advanced artificial intelligence and bioelectronic medicine to develop a new category of therapeutics, known as AI therapeutics. Spun out of the University of Minnesota in 2019, the company focuses on decoding and modulating neural signals through cloud-connected neurotechnology. Their approach integrates AI with the body’s inherent systems to provide safe, progressive, and adaptive treatments for neurological conditions.

Fasikl’s product portfolio includes the FDA-cleared Felix NeuroAI™ Wristband, a non-invasive, AI-powered wearable designed to deliver all-day, personalized tremor relief for adults with essential tremor. This device continuously monitors and adjusts neurostimulation based on real-time neural activity. Additionally, Fasikl is developing investigational implantable peripheral nerve systems, such as the Fasikl-X™ Nerve-Computer Interface (formerly MindForce™), aimed at intuitive prosthetic control for amputees and addressing post-amputation pain.

The company is committed to rigorous clinical validation, with the Felix wristband demonstrating statistically significant superiority over sham in pivotal trials. Fasikl’s mission is to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments by creating intelligent, adaptive, and scalable AI-driven therapies that enhance health and quality of life.

Focus Areas

Neuro-AI bioelectronic medicine artificial intelligence neuromodulation movement disorders essential tremor paralysis neural-interface technologies prosthetic control pain therapy

Business Intelligence

Key InvestorsiSeed, Tailwinds Ventures
PartnershipsMCRA, Tigermed US, Google for Startups Cloud Program
AcquisitionsNone
TechnologyCloud-based AI platform, proprietary neural signal capture from peripheral nerves, adaptive AI models, neuro-microchips, closed-loop transcutaneous neurostimulation, peripheral nerve recording at fascicle/fiber resolution, embedded microelectronics for neural interfaces, real-time intention decoding / brain-machine interface
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Neuro-AI & Artificial Intelligence
Fasikl is a pioneering neuro-AI company that leverages proprietary AI technology to decode and modulate neural signals, enabling cloud-based AI to collaborate with the brain for disease management. Their AI models are built on neural signals from the human peripheral nervous system and refined with multimodal patient data.
Bioelectronic Medicine & Neuromodulation
Fasikl redefines bioelectronic medicine by developing adaptive, real-time neurostimulation systems. Their Felix NeuroAI Wristband delivers closed-loop transcutaneous neurostimulation, modulating the nervous system to alleviate tremor-related functional limitations.
Movement Disorders (Essential Tremor)
The Felix NeuroAI Wristband is the world's first FDA-cleared AI-empowered wearable specifically indicated for essential tremor (ET), the most common movement disorder. Clinical trials (TRANQUIL study) have demonstrated significant reductions in tremors and improvements in daily functionality, providing all-day relief for both hands.
Paralysis & Neural-Interface Technologies
Fasikl is developing the investigational MindForceu2122 Nerve-Computer Interface (NCI) System, which has received FDA Breakthrough Device Designations. This system aims to empower paralyzed patients and amputees to intuitively control robotic limbs and computers by translating neural signals into precise motor control and sensory feedback.
Prosthetic Control
A key innovation of the MindForceu2122 NCI System is breakthrough neural decoding, capturing and interpreting neural signals at a single-fascicle resolution for unmatched accuracy in controlling robotic limbs and other assistive technologies.
Pain Therapy
The MindForceu2122 NCI System also offers targeted neuromodulation to alleviate chronic neuropathic pain resulting from amputation. Fasikl's investigational Epioneu2122 system also focuses on post-amputation pain relief and has received FDA Breakthrough Device Designation.
Physician Tip

For physicians, Fasikl offers a clinically validated, non-invasive, and drug-free alternative or adjunct therapy for essential tremor with the Felix NeuroAI Wristband. Its personalized, adaptive, and continuous AI-driven therapy provides all-day relief and addresses unmet needs for patients dissatisfied with current pharmacological or surgical options. Physicians should educate patients on the importance of consistent wear and monitor progress based on objective measures of tremor reduction and improved daily activities. Additionally, staying informed about Fasikl's pipeline, including the MindForceu2122 NCI System, is crucial for future applications in paralysis, prosthetic control, and chronic neuropathic pain, as these represent significant advancements in neurotechnology.

The Felix NeuroAI Wristband system utilizes a smartphone application for patient interaction and cloud connectivity for AI optimization and continuous learning. This highlights the need for secure data exchange and potential integration with electronic health records (EHR) for streamlined patient management and data-driven insights. For future implantable devices like MindForceu2122, seamless integration with surgical workflows, rehabilitation programs, and existing assistive technologies will be critical for successful adoption and patient benefit.

Products by Fasikl

1 product in the directory

Felix NeuroAI System
Fasikl Incorporated
Neurology AI
Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. Its Felix NeuroAI™ Wristband is the first FDA-cleared AI therapeutic for essential tremor, providing non-invasive, personalized neuromodulation.

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Press & Coverage

HLTH
FDA Clears Fasikl's AI-Powered Wristband for Essential Tremor
University of Minnesota spinout Fasikl received FDA clearance for its AI-powered Felix NeuroAI Wristband, designed to treat essential tremor. The prescription, cloud-connected device delivers personalized stimulation therapy based on real-time feedback to help interrupt tremors.
2025-07
Business Wire (via Fasikl)
Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor
Fasikl announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Felix NeuroAIu2122 Wristband for tremor-related functional limitations in adults with essential tremor. This marks a significant step forward in noninvasive, personalized treatment options.
2025-07
Fasikl
Fasikl Secures $26.5 Million in Series B Venture Capital Investment
Fasikl closed a $26.5 million Series B funding round to accelerate the development and commercialization of next-generation AI therapeutics for essential tremor and other neurological disorders. The funds will support R&D, clinical applications, and user experience improvements.
2025-09
Business Wire (via Fasikl)
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 showing that its FDA-cleared Felix NeuroAIu2122 Wristband significantly improved daily function for people living with essential tremor. The multicenter, randomized, double-blind, sham-controlled clinical trial evaluated 125 adults.
2025-10
Business Wire (via Fasikl)
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 superiority of the Felix NeuroAIu2122 wristband over a sham device in reducing essential tremor symptoms and improving daily activities. Results were presented at the 2025 American Academy of Neurology annual meeting.
2025-04
Fasikl
Zhi Yang, CEO of Fasikl, Speaks with the Star Tribune About New Brain-Machine Interface Research and AI Therapeutics
Zhi Yang, CEO of Fasikl, discussed the company's journey from gaming technology to developing the FDA-cleared Felix NeuroAIu2122 Wristband for essential tremor. He also shared his vision for the evolution of AI in advancing medical technologies.
2025-07
Essential Tremor
Fasikl Product Studies Show Improved Functioning for Patients With Movement Disorders
Fasikl announced the completion of two prospective studies for their Felix NeuroAIu2122 Wristband, showing favorable comparison against existing therapies for essential tremor with minimal side effects and high patient satisfaction. The company is initiating a pivotal study, TRANQUIL, in Q1 2024.
2024-01
Fasikl
Fasikl Unveils Breakthrough Neural Technology Platform
Fasikl announced two simultaneous FDA Breakthrough Device Designations for its minimally invasive implantable platform, the MindForceu2122 NCI System and the Epioneu2122 system, aimed at prosthetic control and post-amputation pain relief. The platform uses AI to perform real-time analysis and decoding of human intentions.
2023-07

Frequently Asked Questions

Fasikl develops AI-powered neural interface technologies designed to restore function and alleviate symptoms for patients with neurological conditions. Our flagship products include adaptive neuromodulation systems for essential tremor and advanced prosthetic control solutions for paralysis, leveraging real-time neural data processing.
Fasikl adheres to stringent regulatory standards, including FDA and CE mark requirements, for all our medical devices. We implement robust cybersecurity protocols and comply with HIPAA and GDPR guidelines to ensure patient data privacy and security throughout our systems.
Fasikl offers competitive pricing structures for our advanced therapies, recognizing the value they bring to patient outcomes. We provide dedicated support and resources to assist healthcare providers with navigating reimbursement pathways and maximizing patient access to our innovative solutions.
Fasikl is committed to comprehensive clinical support, offering extensive training programs for physicians and their staff on product implantation, programming, and patient management. Our dedicated field support teams and 24/7 technical assistance ensure optimal device performance and patient care.
Yes, Fasikl actively collaborates with leading academic research centers, hospitals, and industry partners to advance the field of Neuro-AI and bioelectronic medicine. These partnerships drive innovation, facilitate clinical trials, and expand the therapeutic applications of our technologies.
Fasikl's vision is to revolutionize neurological care through intelligent bioelectronic solutions, continuously investing in R&D and strategic growth. Our strong financial backing, experienced leadership, and robust product pipeline ensure long-term stability and a commitment to pioneering future advancements.
Fasikl's AI-driven neuromodulation platforms offer personalized and adaptive pain therapy by precisely targeting neural pathways involved in chronic pain. This approach aims to provide more effective, sustained relief with fewer side effects compared to conventional pharmacological or less adaptive stimulation methods.

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