Cala Secures FDA Clearance for Innovative Wearable Device Addressing Essential Tremor and Parkinson's Disease
Cala Secures FDA Clearance for Groundbreaking kIQ Plus Device
Cala Health, a pioneering name in the field of bioelectronic medicine, has just announced a significant breakthrough in the treatment of essential tremor (ET) and Parkinson's disease (PD). The U.S. Food and Drug Administration (FDA) has granted clearance for their latest wearable device, the Cala kIQ Plus, which represents the next generation of TAPS® Therapy technology.
A New Era in Tremor Relief
The Cala kIQ Plus is designed not only to provide tremor relief but also to enhance the overall patient experience through personalized treatment options. This state-of-the-art device incorporates new therapy modes and adaptive calibration features to better cater to individual needs. According to Deanna Harshbarger, CEO of Cala, this innovative device empowers patients with greater control over their tremor management process, enabling them to decide when, where, and how to use the therapy.
“We are excited about the potential of the Cala kIQ Plus to significantly improve the lives of individuals living with essential tremor and Parkinson's disease,” said Harshbarger. “This device marks a pivotal moment in wearable neuromodulation technology by offering more customizable options for treatment.”
Upcoming Presentation at AAN 2026
Cala will showcase the Cala kIQ Plus at the forthcoming American Academy of Neurology (AAN) conference scheduled to take place in Chicago from April 18 to 22, 2026. The company is set to present clinical study data highlighting the improved efficacy of the device through its various therapy modes. This data will be shared during a poster presentation titled, “Optimizing Transcutaneous Afferent Patterned Stimulation Therapy Comparison of Variable Waveforms,” on April 20 at 11:45 AM CT.
About Cala Health
Founded with the mission to redefine chronic disease management, Cala Health has been at the forefront of merging neuroscience and technology. The company specializes in wearable neuromodulation therapies that deliver individualized treatments to enhance the standard of care. The original Cala kIQ device is notable for being the only FDA-cleared wearable solution that addresses action hand tremors in individuals suffering from ET and PD, providing temporary relief through TAPS therapy.
The Cala kIQ device aids in managing tremors that interfere with daily activities, ensuring those affected can regain some control over their symptoms. The device is now available to eligible Veterans Affairs (VA) beneficiaries at no cost, alongside Medicare coverage for qualified users, a move that demonstrates Cala's commitment to making its technology accessible.
Cala Health continues to advocate for expanded coverage in both Medicare Advantage and commercial payor plans, reinforcing its dedication to enhancing the quality of life for patients dealing with essential tremor and Parkinson's disease.
Conclusion
With the FDA clearance of the Cala kIQ Plus, patients suffering from essential tremors and Parkinson's disease can look forward to a new companion in their treatment journey, characterized by a mix of cutting-edge technology and personalized care. This innovative device has the potential to change lives, making everyday tasks less daunting and opening up new possibilities for improving life quality. As Cala prepares for its presentation at AAN 2026, the future looks bright for advancements in wearable therapeutic devices.