Cala Health Secures FDA Clearance for Next-Gen Wearable Tremor Device Cala kIQ Plus

New updates have been reported about Cala Health.

Cala Health has received U.S. Food and Drug Administration clearance for Cala kIQ Plus, the next generation of its wearable neurostimulation system for action hand tremor in essential tremor and Parkinson’s disease, marking a significant product upgrade in its TAPS-based portfolio. The new device adds therapy modes and adaptive calibration intended to optimize tremor relief and personalize treatment, giving patients more control over how and when therapy is delivered.

The company plans to highlight Cala kIQ Plus and supporting clinical data at the American Academy of Neurology 2026 meeting in Chicago, where study results will show improved efficacy and responder rates with the new therapy modes, including bilateral tremor improvement in essential tremor. With its kIQ platform already the only FDA-cleared wearable for action hand tremor in both essential tremor and Parkinson’s disease, Cala Health is positioned to deepen penetration in Medicare and Veterans Affairs channels while it continues to pursue broader reimbursement from Medicare Advantage and commercial insurers, supporting a direct-to-home digital DME strategy and expanding access for chronic movement disorder patients.