FDA Clears First AI-Powered Wristband for Essential Tremor Treatment
- The FDA has granted 510(k) clearance for the Felix NeuroAI Wristband, the first AI-driven wearable device approved for treating tremor-related functional limitations in adults with essential tremor.
- The noninvasive device connects to a cloud-based AI platform to deliver personalized, adaptive stimulation throughout the day, offering an alternative to surgery and medications for the approximately 7 million Americans affected by essential tremor.
- Clinical trial data from the TRANQUIL study demonstrated significant tremor reduction and improved daily function with no serious device-related side effects, with the device expected to be available by prescription in select U.S. regions in 2025.