FDA Clears Cala kIQ Plus for Essential Tremor and Parkinson Disease Hand Tremor
Summary
The FDA cleared Cala kIQ Plus, an updated wearable transcutaneous afferent patterned stimulation system, for temporary relief of action hand tremor in essential tremor and postural and kinetic hand tremor symptoms in Parkinson disease. The next-generation device builds on the previously cleared Cala kIQ platform with new therapy modes and adaptive calibration designed to personalize stimulation and optimize tremor control. Cala received FDA clearance through the 510(k) pathway in March 2026.
Why it matters
This clearance expands treatment options for the more than 7 million Americans living with essential tremor and the many Parkinson's patients experiencing debilitating hand tremors. As a non-invasive, wearable alternative to medication or surgery, Cala kIQ Plus represents the type of patient-centric neurotechnology that can be used at home and integrated into daily life, potentially improving quality of life for millions.
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