FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

NeuroMetrix Begins Shipping Quell Device

June 1, 2015

NeuroMetrix reported Thursday that it has initiated its first Quell wearable pain relief device shipments to U.S. healthcare providers. The product was FDA 510(k)-cleared for chronic pain treatment without a prescription in 2014.

Quell features noninvasive neurostimulation technology to alleviate pain in patients with diabetic nerve pain, low back and leg pain, fibromyalgia and osteoarthritic pain, among others. The device is lightweight and meant to be worn during the day and the night.

Quell users can use a smart phone app to track and customize their therapy, the Waltham, Mass., company says.

The devicemaker will seek CE Mark approval for the product this year, a spokesman told Device Daily Friday.

NeuroMetrix designs wearable medical technology and point-of-care tests for chronic pain, nerve disease and sleep disorder management. — Jason Scott