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NeuroMetrix (NASDAQ:NURO) stock is surging higher on Tuesday after getting “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA).

The breakthrough designation is for NeuroMetrix’s Quell device designed to treat symptoms in adult patients suffering from fibromyalgia. This is due to the unmet need for managing pain from fibromyalgia without pharmacological treatments.

While there are medicines to treat the pain of fibromyalgia, NeuroMetrix seeks to help manage it further with Quell. The device is only the size of a credit card and can connect to the company’s app via Bluetooth to assist with fibromyalgia managment.

It’s worth pointing out that the designation for Quell comes after a clinical trial. This double-blind study saw 119 patients enrolled. Of those on Quell, 56% reported a clinically meaningful improvement in health-related quality-of-life. For comparison, only 35% achieved that in the sham group.

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Shai N. Gozani, M.D., Ph.D., president and CEO of NeuroMetrix, had the following to say about the news sending NURO stock higher today.

“The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia. We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”

To go along with this news, NURO stock is seeing incredibly heavy trading today. As of this writing, more than 37 million shares of the stock have changed hands. That’s quite the increase compared to its daily average trading volume of around 114,000 shares.

NURO stock was up 42.6% as of Tuesday morning.

Of course, there is more going on with the market today that’s worth looking into.

Luckily, InvestorPlace has it covered. That includes the latest stock news concerning Peloton (NASDAQ:PTON), Ardelyx (NASDAQ:ARDX), and Nvidia (NASDAQ:NVDA). You can learn all about this at the links below!

More Monday Stock Market News

• PTON Stock: The UNH Deal Giving Peloton Shares a Jump Today
• ARDX Stock: Disastrous FDA News Sends Ardelyx Shares Plummeting
• Nvidia Stock Split 2021: What NVDA Investors Should Know as the 4-for-1 Split Goes Into Effect

On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

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