Cala Health announced US Food and Drug Administration clearance of the Cala kIQ Plus system, the next-generation wearable neurostimulation device for action hand tremor in essential tremor and Parkinson’s disease.
According to the company, kIQ Plus introduces new therapy modes and adaptive calibration designed to optimize tremor relief and personalize treatment, providing an intuitive experience when tremor control is needed.
The company will present clinical data on kIQ Plus at the American Academy of Neurology meeting in Chicago, April 18 to April 22, with a poster presentation on April 20 at 11:45 a.m. CT (poster P 5-005) comparing variable waveforms and reporting increased responder rates and bilateral tremor improvement in essential tremor.
The Cala kIQ System is indicated to provide temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor, and to provide temporary relief of postural and kinetic hand tremor symptoms that affect some activities of daily living in the treated hand in adults with Parkinson’s disease.
The system is available through the Veterans Affairs Health System for eligible beneficiaries and is covered by Medicare for those who meet local coverage criteria.
