FDA Clears Cala’s Wearable Device for Essential Tremor and Parkinson’s Disease

Cala has earned U.S. Food and Drug Administration (FDA) clearance for the Cala kIQ Plus system, the next-generation of its wearable neurostimulation device for action hand tremor in essential tremor (ET) and Parkinson’s disease (PD).

Cala kIQ Plus is reportedly the latest advancement in TAPS technology—introducing new therapy modes and adaptive calibration that optimizes tremor relief and personalizes treatment to give patients an intuitive experience when tremor control is necessary.

“Cala continues to elevate the patient experience and therapy outcomes by advancing wearable neuromodulation technology that treats action hand tremor in essential tremor and Parkinson’s disease. The Cala kIQ Plus system gives patients more control over how, when, and where TAPS Therapy is delivered for tremor management,” Cala CEO Deanna Harshbarger stated. “We will present the latest data on Cala kIQ Plus at the American Academy of Neurology conference in Chicago.”

Cala will showcase Cala kIQ Plus at AAN 2026 (Booth Number 5024). Clinical study data on Cala kIQ Plus showing improved efficacy with therapy modes will be presented on April 20 at 11:45 am CT in poster presentation P5-005 entitled, “Optimizing Transcutaneous Afferent Patterned Stimulation Therapy: Comparison of Variable Waveforms Reveals Increased Responder Rates and Bilateral Tremor Improvement in Essential Tremor.”

Cala Health is a bioelectronic medicine company striving to transform the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its direct-to-home digital durable medical equipment (DME) platform is reshaping the delivery of prescription therapies.

The Cala kIQ System is an FDA-cleared wearable device that delivers therapy for action hand tremor in adult patients with essential tremor and Parkinson’s disease. The Cala kIQ device temporarily relieves hand tremors in the treated hand after stimulation in patients with essential tremor and Parkinson’s disease. The Cala kIQ device delivers TAPS therapy, which provides transcutaneous afferent patterned stimulation. The Cala system is available through the Veterans Affairs (VA) Health System at no cost to eligible VA beneficiaries and has Medicare coverage for those who meet Local Coverage Criteria.