FDA Clears Cala kIQ Plus for Essential Tremor and Parkinson Disease Hand Tremor

According to a new announcement, the FDA has cleared Cala kIQ Plus, an updated wearable transcutaneous afferent patterned stimulation (TAPS) system, for temporary relief of action hand tremor in essential tremor (ET) and postural and kinetic hand tremor symptoms in Parkinson disease (PD).¹

Developed by Cala Health, the next-generation device builds on the previously cleared Cala kIQ platform, incorporating new therapy modes and adaptive calibration designed to personalize stimulation and optimize tremor control.¹ The clearance was granted through the 510(k) pathway based on substantial equivalence to the prior device, with updates primarily focused on software, calibration, and usability enhancements rather than a new pivotal efficacy trial.²

“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," Deanna Harshbarger, chief executive officer at Cala, said in a statement.¹ "We will present the latest data on Cala kIQ Plus at the American Academy of Neurology conference in Chicago."

The clinical rationale for TAPS therapy is supported by a growing body of evidence demonstrating that peripheral nerve stimulation targeting the median and radial nerves can modulate central tremor circuits. In an early sham-controlled pilot study published in Movement Disorders, noninvasive neuromodulation resulted in significant improvement in tremor severity as assessed by blinded spiral-drawing tasks, providing proof of concept for the approach.³

Subsequent data have suggested that these effects may persist beyond the stimulation period. In a 2020 study published in Frontiers in Neuroscience, 80% of patients with ET demonstrated improvement in tremor severity lasting at least 60 minutes after therapy, with more than 70% showing sustained reductions in tremor power across motor tasks.⁴

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Longer-term outcomes have been evaluated in a prospective home-use study of 263 patients with ET, published in Tremor and Other Hyperkinetic Movements. Among the 205 participants who completed 3 months of therapy, 62% improved from severe or moderate tremor to mild or slight based on clinician-rated TETRAS scores, while 68% showed similar improvements on patient-reported activities of daily living.5 Device-recorded data from more than 21,000 treatment sessions demonstrated that 92% of patients experienced improvement after stimulation, with 54% achieving at least a 50% reduction in tremor power.⁵

Safety findings from the same study indicated that device-related adverse events occurred in 18% of patients and were primarily mild, including wrist discomfort and skin irritation, with no reported device-related serious adverse events.⁵

Although these data provide the foundation for the TAPS platform, most published evidence has been generated in ET populations, with more limited data specific to PD. The Cala kIQ Plus clearance therefore represents an incremental advancement of an existing technology rather than a new class of therapy, with forthcoming data—expected to be presented at the 2026 American Academy of Neurology Annual Meeting—anticipated to further define its clinical impact.¹

From a clinical perspective, wearable neuromodulation devices such as Cala kIQ Plus offer a noninvasive, on-demand treatment option that may complement pharmacologic therapy, particularly in patients with suboptimal response or tolerability to medications. However, the device is intended for temporary symptomatic relief in the treated hand and does not modify disease progression, positioning it as an adjunct rather than a replacement for established therapies.²

REFERENCES
1. Cala Health. Cala announces FDA clearance of its next generation TAPS therapy wearable device for essential tremor and Parkinson’s disease. News release. April 15, 2026.
2. US Food and Drug Administration. 510(k) summary: Cala kIQ Plus (K253587). March 17, 2026.
3. Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial. Mov Disord. 2018;33(7):1182-1183.
4. Yu JY, Rajagopal A, Syrkin-Nikolau J, et al. Transcutaneous afferent patterned stimulation therapy reduces hand tremor for one hour in essential tremor patients. Front Neurosci. 2020;14:530300.
5. Isaacson SH, Peckham E, Tse W, et al. Prospective home-use study on non-invasive neuromodulation therapy for essential tremor. Tremor Other Hyperkinet Mov (N Y). 2020;10:29.