Cala kIQ System
FDA-cleared wearable device delivering on-demand therapy for action hand tremor
Device · EmbeddedCompany source
Company profile
About Cala Health
Cala Health is a medical device company that has developed the Cala kIQ System, the only FDA-cleared wearable device for treating action hand tremor in people with essential tremor and Parkinson's disease. The company's proprietary TAPS (Transcutaneous Afferent Patterned Stimulation) therapy delivers individualized, non-invasive neuromodulation through a wrist-worn device. The technology works by sensing each patient's unique tremor signature and delivering personalized electrical stimulation through the nerves from the wrist to the brain to counteract tremor. Clinical studies demonstrate that 9 out of 10 people experience tremor reduction with a complete 40-minute session, with relief lasting over 90 minutes on average after treatment. The therapy is physician-prescribed and can be used multiple times daily, on-demand before activities affected by tremor such as eating, writing, or drinking. Cala Health's solution addresses the needs of over 7 million Americans struggling with essential tremor, offering a safe alternative that can be used alongside medications or when medications are not meeting patient needs. The company provides patients with data insights through the MyCala patient portal, allowing them to track results over time and share reports with healthcare providers. The Cala kIQ System is covered by Medicare for qualifying beneficiaries, the VA for veterans, and many commercial insurance plans.
Company description Cala Health official website
Primary marketChronic Disease Management & Digital Therapeutics
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Action hand tremor
- Essential tremor
- Parkinson's disease (with action tremor component)
Who it serves
- Healthcare providers
- Movement disorder specialists
- Neurologists
- Patients with essential tremor
- Patients with Parkinson's disease
- Veterans Affairs facilities
Deployment & integration
Cloud Saas · Embedded deployment with recorded integration context.
Geographic context
MarketsUnited States
Company sourceOfficial website
Company milestones
Platform expansion
Medicare coverage approved for qualifying beneficiaries (2024-2025 timeframe based on website messaging). Multiple peer-reviewed publications in 2022-2023 including largest prospective device study in essential tremor (N=310) and long-term real-world evidence up to 3.4 years of use.
Partnerships
Recorded partners
- CVS Health/Aetna (clinical trial partner)
- Medicare
- VA (Veterans Affairs)
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Cala TAPS Therapy
Transcutaneous afferent patterned stimulation therapy for tremor relief
Other · EmbeddedCompany source
Cala Trio System
Alternative system configuration for tremor therapy
Device · EmbeddedCompany source
MyCala Portal
Patient portal for tracking therapy results and sharing data with clinicians
Platform · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Underlying Tremor Improvement with Consistent Use of Transcutaneous Afferent Patterned Stimulation in Patients with Essential Tremor.Tremor and other hyperkinetic movements (New York, N.Y.) · Jan 1, 2026
Clinical and Economic Correlates of Pharmacotherapy in Patients with Essential Tremor.Tremor and other hyperkinetic movements (New York, N.Y.) · Jan 1, 2024
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies.Expert review of medical devices · Jan 1, 2023
Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson's Disease.Tremor and other hyperkinetic movements (New York, N.Y.) · Jan 1, 2023
Transcutaneous Afferent Patterned Stimulation for Essential Tremor: Real-World Evidence with Long Term Follow-Up.Tremor and other hyperkinetic movements (New York, N.Y.) · Jan 1, 2023
Editorial: Peripheral stimulation: neuromodulation of the central nervous system through existing pathways.Frontiers in neuroscience · Jan 1, 2023
Clinical validation
Clinical-trial records
Long-Term Transcutaneous Stimulation and Essential Tremor: A PET StudyNCT03778060 · Sponsor · ACTIVE NOT RECRUITING
RWE Study Utilizing the Cala Trio Device in Patients With Essential TremorNCT05540626 · Sponsor · COMPLETED
Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action TremorNCT05012579 · Sponsor · COMPLETED
Prospective Study for Symptomatic Relief of ET With Cala TherapyNCT03597100 · Sponsor · COMPLETED
Cala ONE Device for Essential TremorNCT02629614 · Sponsor · COMPLETED
Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative ColitisNCT05662059 · Sponsor · UNKNOWN
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
9 out of 10 people experience tremor reduction
with complete 40-minute therapy session
94 minutes average tremor relief duration
after therapy session (median 60 min, SD 138 min)
64% average reduction in tremor power
measured by motion sensors in real-world evidence study
Significant improvement in Bain & Findley ADL scores
over one month compared to standard of care alone
CVS Health/AETNA
Randomized pragmatic trial comparing TAPS therapy plus standard of care versus standard of care alone for essential tremor
Significant improvements in tremor power and Bain & Findley Activities of Daily Living upper limb scores over one month (N=310, largest prospective device study in essential tremor)
Ben (Retired Air Force veteran)
Treating tremors to regain normal function
Gradual improvement in tremors, feeling near-normal again
Beverly (Cala user)
Managing tremor to restore ability to participate in social and political activities
Regained ability to attend meetings and remain politically active
Holly (Ministry volunteer and grandmother)
Managing essential tremor to improve daily activities including reading, cooking, eating and drinking
Able to hold book steady while reading, cut vegetables with more control, and eat/drink without spilling
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Cala Health
Recent articles published on Cala Health's official website.
No Company updates are currently listed.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Chronic Disease Management & Digital Therapeutics
Companies using AI and digital health tools to help patients manage chronic conditions through digital therapeutics, gamified health management, and AI-powered coaching. Covers management of all chronic diseases including diabetes, hypertension, COPD, heart disease, and multi-condition platforms. Includes continuous glucose monitoring (CGM) systems with AI analytics and insulin optimization algorithms.
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Linked research, clinical, and regulatory source pathways.
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Record-level provenance and review context.