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Media & Clinical Announcements

Fasikl News & Insights

Official corporate announcements, peer-reviewed trial data, FDA regulatory milestones, and global partnership news.

Official Communications

Latest Clinical Milestones & Press Releases

Discover how Fasikl is advancing Neuro-AI therapeutics through peer-reviewed research, regulatory authorizations, and strategic global capital investments.

Press Release | October 20, 2025

Data Published in JAMA Neurology Demonstrates Fasikl's AI-Powered Wristband Improves Daily Function for People with Essential Tremor

A randomized clinical trial published in JAMA Neurology demonstrates clinically meaningful and statistically significant improvements in activities of daily living and overall quality of life for essential tremor patients using the Felix NeuroAI™ Wristband. The clinical evidence highlights sustained efficacy through noninvasive closed-loop peripheral nerve modulation.

Corporate Growth | September 10, 2025

Fasikl Secures $26.5 Million in Series B Venture Capital Funding

Fasikl closed an oversubscribed $26.5 million Series B equity round to accelerate the global commercialization of its FDA-cleared Felix NeuroAI Wristband and advance next-generation neural interface research across international medical centers.

Executive Media | July 18, 2025

Zhi Yang, CEO of Fasikl, Features in Star Tribune Discussion on Brain-Machine Interfaces and AI Therapeutics

In an exclusive executive feature, Fasikl CEO Zhi Yang discussed the enterprise journey from advanced neural signal processing R&D to achieving market clearance for the world's first FDA-authorized AI therapeutic wearable targeting essential tremor.

Regulatory Milestone | July 1, 2025

Fasikl Receives FDA Clearance for Felix NeuroAI Wristband as First AI-Powered Essential Tremor Therapy

The U.S. Food and Drug Administration (FDA) granted market clearance for the Felix NeuroAI Wristband. Powered by proprietary cloud-AI signal decoding algorithms, the prescription wearable delivers noninvasive, drug-free tremor relief for adults living with essential tremor.

Industry Keynote | May 21, 2025

National Academy of Engineering Keynote: AI Therapeutics in Bioelectronic Medicine

Speaking at the National Academy of Engineering Regional Meeting hosted at Medtronic, Fasikl presented breakthroughs in closed-loop bioelectronic medicine, showing how cloud artificial intelligence adapts stimulation dynamically based on real-time neuromuscular data.

Clinical Trial Data | April 9, 2025

Pivotal TRANQUIL Study Results Presented at American Academy of Neurology (AAN)

Late-breaking clinical results from the pivotal TRANQUIL study demonstrated statistical superiority of the Felix NeuroAI Wristband over sham devices, proving significant tremor magnitude reduction and restored motor dexterity in adult patients.

Strategic Partnership | January 7, 2025

Fasikl Selected for Google for Startups Cloud Program to Scale Neural Machine Learning Models

Fasikl joined the Google for Startups Cloud Program, leveraging high-performance cloud compute infrastructure to train multi-channel neural signal models and accelerate real-time adaptive AI therapy deployment globally.

Series A Capital | September 10, 2024

Fasikl Closes $18.3 Million Series A+ Investment Co-Led by iSeed and Tailwinds Ventures

Expansion capital co-led by prominent life-science venture funds supports ongoing pivotal clinical trials, quality system expansion, and international regulatory preparation for noninvasive neuro-AI therapeutics.

Global Commercial Cooperation

Partnering with Medical Distributors & Neurological Centers

Fasikl partners with movement disorder centers, clinical research organizations, and authorized medical device distributors across North America, Europe, Asia-Pacific, and the Middle East.

Regulatory Compliance & ISO 13485

Our engineering and manufacturing operations strictly adhere to ISO 13485 quality management systems and FDA QSR requirements, providing full technical dossiers for regional regulatory submissions.

International Clinical Support

We provide medical providers and distribution partners with comprehensive clinician training, patient onboarding materials, clinical trial documentation, and cloud analytics dashboards.