NeuroMetrix Submits FDA De Novo Request For Treatment Of Fibromyalgia Symptoms With Quell

NeuroMetrix Inc. (NURO) said that it has submitted a De Novo request to the U.S. Food and Drug Administration for Quell Wearable Neuromodulation Device as a prescription treatment for the symptoms of fibromyalgia in adults. The company received FDA Breakthrough Designation for this indication in July.

NURO closed Wednesday regular trading at $8.62 down $0.76 or 8.10%. But in the after-hours trade, the stock gained $1.23 or 14.27%.

The company hopes to commercially launch Quell for this indication in the second half of 2022.

Fibromyalgia is a chronic pain condition that is accompanied by fatigue, sleep, cognitive and mood disturbances. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. There are currently no medical devices with FDA clearance or approval for treating fibromyalgia.

The De Novo pathway for marketing authorization is available to low-to-moderate risk medical devices that do not have a cleared predicate device, and are therefore not eligible for the pre-market notification process (i.e., 510(k)).

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Variety store chain Family Dollar is recalling around 38,300 units of beach loungers citing injury risk, the U.S. Consumer Product Safety Commission said. The recall involves beach lounge chairs with a white metal frame and either red or blue woven plastic fabric. The lounge chairs have a hang tag intended to be removed after purchase. Aerospace giant Boeing Co. (BA) on Wednesday reported fourth-quarter net loss attributable to Boeing shareholders of $4.16 billion or $7.02 per share, sharply narrower than $8.44 billion or $14.65 per share in the year-ago quarter. The 787 program recorded $3.5 billion pre-tax non-cash charge; focused... Telecom giant AT&T reported Wednesday a profit for the fourth quarter compared to a loss last year, primarily boosted by continuing customer growth in wireless, fiber and HBO Max, despite a 10 percent drop in revenues. Both adjusted earnings for the quarter and quarterly revenues also topped analysts' expectations. However, the company issued weak earnings and sales growth outlook for fiscal 2022.
Follow RTT