Wearable technology from Neurometrix The FDA has given the Quell gadget a breakthrough designation.

Wearable technology from Neurometrix The FDA has given the Quell gadget a breakthrough designation.
Wearable technology from Neurometrix The FDA has given the Quell gadget a breakthrough designation.

Fibromyalgia is a severe illness marked by persistent pain throughout the body, leaving sufferers exhausted, despondent, and unable to do even the most basic of tasks. While a few medicines have been authorized to treat this autoimmune condition, they can have severe side effects and aren’t effective for everyone. To that aim, the FDA has designated Neurometrix Inc.’s Quell wearable neurostimulation device as a breakthrough product for treating the symptoms of fibromyalgia in adults.

NeuroMetrix’s stock surged on Tuesday after the firm revealed that one of its flagship neurostimulation devices has gained breakthrough designation from the Food and Drug Administration.

As of 12:30 p.m. ET, investors had rushed on the stock, pushing it up 170 percent. The stock began trading at $4 on Tuesday, but by lunchtime, it was trading in the $9 area.

The FDA has approved the company’s Quell gadget to aid individuals with fibromyalgia symptoms. Chronic pain affects between 5 and 15 million persons in the United States, most of whom are between the ages of 30 and 50. It frequently results in tiredness, as well as cognitive and emotional problems.

The FDA has approved the company’s Quell gadget to aid individuals with fibromyalgia symptoms. Chronic pain affects between 5 and 15 million persons in the United States, most of whom are between the ages of 30 and 50. It frequently results in tiredness, as well as cognitive and emotional problems.

Quell is a wearable gadget that stimulates nerves and promises to reduce pain, according to NeuroMetrix. The FDA will grant the device priority evaluation as a result of the breakthrough designation, which might lead to Medicare reimbursement for Quell purchasers.

NeuroMetrix found that 56 percent of individuals who used the Quell for three months exhibited a “clinically substantial improvement” in health-related quality of life in a double-blind trial of 119 patients with fibromyalgia.

Quell might debut particularly for fibromyalgia patients in the second half of the year, according to the firm, which is pressing forward with a regulatory application. (At the moment, the gadget is simply offered as a pain-relief band, with no mention of specific health concerns.)

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