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# Cala Health Get Breakthrough Status for Hand Tremors
- URL: https://www.fdaweb.com/cala-health-get-breakthrough-status-for-hand-tremors/
- Published: 2020-10-22T12:00:00.000Z
- Updated: 2026-09-14T16:33:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147939

FDA has granted Cala Health a breakthrough device designation for its Cala Trio targeted therapy for treating action tremors in the hands of adults with Parkinson’s disease. Cala Trio is currently FDA-cleared to relieve hand tremors from essential tremor. The company expects to begin clinical trials evaluating the therapy in treating action hand tremors by the end of the year. Cala Trio is described by the company as a non-invasive targeted therapy using a wrist-worn device that is calibrated to treat a patient's unique tremor symptoms. “When activated, Cala Trio gently stimulates the nerves in the wrist to disrupt the tremulous activity in the brain, without the need for invasive brain surgery or medication,” the company says.