This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

NeuroMetrix Files 510(k) For SENSUS™ Pain Therapy Device

Stocks in this article: NURO

NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that it has filed a premarket notification, or 510(k), with the Food and Drug Administration (FDA) for its SENSUS Pain Therapy device.

SENSUS is a non-invasive transcutaneous electrical nerve stimulator intended to be used in the symptomatic relief and management of chronic intractable pain, such as painful diabetic neuropathy. SENSUS employs the same sophisticated nerve stimulation technology as the Company’s NC-stat ® DPNCheck™ device, and includes advanced features that the Company believes may address the technical and clinical limitations of existing nerve stimulators. The device also includes technology to maximize patient compliance, which is one of the fundamental challenges with pain therapy.

Painful diabetic neuropathy affects as many as 10-20% of people with diabetes, and is a serious and disabling complication of diabetic peripheral neuropathy (DPN). The pain is typically managed pharmacologically; however, many patients remain undertreated. Recent evidence based reviews have suggested that transcutaneous electrical nerve stimulators may be useful in managing painful diabetic neuropathy.

“The filing of a 510(k) for SENSUS represents a key milestone in this product development program,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer, NeuroMetrix. “We look forward to feedback from the FDA and working towards a timely clearance. Once commercialized, we believe that SENSUS will complement NC-stat DPNCheck, our sural nerve conduction test for DPN, and move us towards our goal of creating a unique and valuable diabetic neuropathy product portfolio and franchise.”

About NeuroMetrix

NeuroMetrix is a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes. The Company currently markets products for the detection, diagnosis, and monitoring of diabetic neuropathies such as diabetic peripheral neuropathy and median neuropathy (carpal tunnel syndrome). For more information, please visit http://www.neurometrix.com.



1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,416.85 +225.48 1.31%
S&P 500 2,021.25 +19.09 0.95%
NASDAQ 4,683.4070 +45.4130 0.98%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs