FDA clears Cala kIQ Plus, next-generation TAPS wearable for essential tremor and Parkinson's hand tremor

Cala Health/Cala kIQ Plus

Cala received FDA 510(k) clearance for the kIQ Plus wearable tremor-relief device, adding new therapy modes and adaptive calibration to personalize nerve stimulation. A 263-patient home study of essential tremor patients showed 62% improved from severe/moderate to mild tremor in 3 months, with 54% achieving ≥50% tremor power reduction. Adverse events were primarily mild.

• kIQ Plus uses transcutaneous afferent patterned stimulation (TAPS), delivering personalized electrical pulses via a wrist-worn device.
• Clinical trial: 62% of 263 patients improved tremor severity; 54% reduced tremor power by ≥50% within 3 months.
• Cleared via 510(k) pathway based on substantial equivalence, with changes focused on software, calibration, and usability.
• Indicated for temporary symptom relief in essential tremor and Parkinson's disease hand tremor; does not modify disease progression.