NeuroMetrix’s Fibromyalgia Device Deemed Breakthrough Device
The FDA has granted NeuroMetrix a Breakthrough Device designation for its Quell neurostimulation device for treatment of fibromyalgia.
The wearable device, which is the size of a credit card, includes a microchip that provides precise nerve stimulation and uses motion sensing to automatically adjust stimulation.
The FDA’s Breakthrough Devices Program allows developers to interact with the FDA's experts to address topics that arise during premarket reviews.
NeuroMetrix CEO Shai Gozani said the company is moving forward with a regulatory filing and hopes to launch the product in the second half of next year.