FOR YOUR
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We are conducting a research study of a non-invasive investigational device designed to help relieve tremors of the hand. You may be eligible if you experience upper limb tremor.
We are conducting a research study of a non-invasive investigational device designed to help relieve tremors of the hand. You may be eligible if you experience upper limb tremor.
We are leveraging advances in wearable technology, signal processing, and patient sensing to provide affordable, personalized, non-invasive remedies for patients with neurological movement disorders. The company is headquartered in the Boston area and backed by leading investors in both healthcare and technology. Our primary goal is getting this useful technology to the people who could benefit from it as soon as possible.
The 47-patient ULTRE study was designed as a double-blind, randomized, sham-controlled, cross-over clinical trial, adhering to rigorous scientific standards. Two distinct vibrotactile stimulation paradigms—Pulsed and Continuous—were compared with an inactive sham control. Participants were required to meet stringent inclusion criteria, ensuring the study’s robustness and clinical relevance.
The Breakthrough Device Program was created to accelerate the path to market for innovative medical devices which demonstrate the promise to substantially improve the standard of care for patients with life-threatening or irreversibly debilitating conditions. The program fast-tracks development, assessment, and review by creating channels for prioritized communication and interaction between developers of new technologies and the experts at the FDA.