Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • Neurology and Neurosurgery
  • Neurology & Neurosurgery News
  • FDA Clears AI-Powered...

FDA Clears AI-Powered Wristband for Essential Tremor Relief

Dr. Kamal Kant KohliWritten by Dr. Kamal Kant Kohli Published On 2025-07-03T20:15:53+05:30  |  Updated On 3 July 2025 8:15 PM IST
FDA
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

The FDA has approved the Felix™ NeuroAI™ Wristband, a wearable AI-driven neurostimulation device, for treating upper limb functional limitations in adults with essential tremor. The cloud-based system delivers personalized therapy, continuously adjusting stimulation throughout the day based on the patient’s needs.

“The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor,” said Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System. “For many patients, current treatment options fall short-pharmaceutical treatments are helpful for less than 50% of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention. This new AI wearable wristband backed by clinical evidence is an effective treatment option in patients with essential tremor.”

Essential tremor is the most common type of tremor disorder, affecting approximately 7 million people in the U.S., and is about seven times more common than Parkinson’s disease. It causes involuntary, rhythmic shaking, most often in the hands, which can make simple and everyday activities like drinking from a glass or tying shoelaces difficult. Traditional treatment options are limited, with oral medications providing inconsistent relief and often accompanied by undesirable side effects.4 Surgical interventions such as deep brain stimulation (DBS), while effective, require invasive procedures, carry surgical risks, and may not be suitable or desirable for all patients, particularly older adults or those with coexisting health conditions.

Unlike surgical or pharmacologic interventions, Felix is a noninvasive, wearable device that effortlessly connects to Fasikl’s cloud-based AI platform, enabling continuous brain-AI co-adaptation and personalized therapy. Worn on the wrist, it uses the cloud to dynamically adjust stimulation, offering all-day symptom relief while seamlessly fitting into the wearer’s lifestyle.

The FDA clearance of Felix is supported by compelling data from the TRANQUIL study, a randomized, double-blind, sham-controlled trial that met its primary endpoint. Results showed that the Felix wristband significantly reduced tremors and displayed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using the sham device (“placebo effect”). Efficacy was consistent across demographics, with no serious device-related adverse events reported. Results were presented as Late-breaking Science at the American Academy of Neurology annual meeting in April 2025, reinforcing Felix’s safety and potential as a first-of-its-kind, noninvasive, AI-powered treatment.

“FDA clearance of Felix marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies,” said Zhi Yang, Ph.D., CEO of Fasikl. “This breakthrough in noninvasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable. Our next step is to execute the commercialization plan to support Felix’s initial product launch."

The Felix NeuroAI Wristband will be available by prescription through healthcare providers in select U.S. regions starting in 2025, with nationwide availability expected in 2026.

FDAUSFDAFelix NeuroAI WristbandtremorParkinson’s diseaseFasikl
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

Show Full Article
Next Story

Editorial

Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension, Dyslipidemia, and Familial ASCVD Risk

Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension,...

Featured image representing thinking

Is Pharma Marketing Going Through "Thinking Recession"?

Beyond BMI: Why Pioglitazone Deserves a Place in Managing Thin-Fat Type 2 Diabetes in India

Beyond BMI: Why Pioglitazone Deserves a Place in Managing 'Thin-Fat' Type 2 Diabetes in India

How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

View All

Journal Club Today

Exfoliation Explained by Dermatologist Dr. Tanvi Vaidya

Exfoliation Explained by Dermatologist Dr. Tanvi Vaidya

View All

Health News Today

Health Bulletin 3/July/ 2025

Health Bulletin 3/July/ 2025

View All
© 2022 All Rights Reserved.
Powered By: Hocalwire
X
We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok