The U.S. Food and Drug Administration has cleared Cala Health’s Cala kIQ Plus, a next‑generation wrist‑worn neurostimulation device for reducing hand tremor in people with Parkinson’s disease and essential tremor.
The device uses Cala’s Transcutaneous Afferent Patterned Stimulation (TAPS) to deliver patterned electrical pulses to nerves in the forearm. Cala says the new kIQ Plus adds multiple therapy modes and an adaptive calibration feature intended to personalize stimulation for individual tremor patterns.
Cala will present clinical data at the American Academy of Neurology annual meeting (April 18–22, 2026). The company’s poster reports pooled results from several studies enrolling 78 patients with functionally limiting arm and hand tremors. Participants tested three TAPS modes — standard, burst‑frequency variation (BFV) and pulse‑frequency variation (PFV) — over six weeks (two weeks per mode).
The company reports that all three modes significantly reduced tremor as measured by TETRAS (the Tremor Research Group Essential Tremor Rating Assessment Scale). In a subgroup of 28 patients who completed the protocol, BFV increased the proportion achieving clinician‑rated functional benefit compared with standard mode (89.3% vs. 80.4%). Cala also notes tremor improvements were bilateral, affecting both the stimulated and nonstimulated arms. These results are being presented as meeting data and are not yet peer‑reviewed.
The kIQ platform records tremor data that patients can share with clinicians via an online portal. Cala says the system uses machine learning to tailor stimulation patterns to measured tremor characteristics.
The company said the device is available through the U.S. Department of Veterans Affairs at no cost to eligible beneficiaries and covered by Medicare for patients who meet local coverage criteria. Cala is seeking broader reimbursement from Medicare Advantage and commercial payors.
“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 said in a company press release.
Photo credit: parkinsonsnewstoday.com
Tags: Cala kIQ Plus, TAPS, Parkinson's disease, wearable neurostimulation, essential tremor
Topics: Non-invasive brain stimulation, Neuromodulation, Wearable neurotech