• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » NeuroMetrix wins FDA nod for over-the-counter chronic pain device

NeuroMetrix wins FDA nod for over-the-counter chronic pain device

July 8, 2014 By Brad Perriello

NeuroMetrix wins FDA nod for over-the-counter chronic pain device

NeuroMetrix (NSDQ:NURO) said today that the FDA granted 510(k) clearance for over-the-counter sales of its wearable chronic pain device based on its Sensus pain management system.

The clearance allows Waltham, Mass.-based NeuroMetrix to sell the device directly to consumers without a doctor’s prescription, according to a press release.

"Patient response to Sensus, our prescription wearable device for treatment of chronic pain, has been very positive since it was launched in early 2013. We believe that there is a substantial consumer market for an over-the-counter version of this technology," president & CEO Dr. Shai Gozani, said in prepared remarks. "The ability to offer both prescription and over-the-counter products will give us maximal market exposure and allow us to reach more people with chronic pain. We anticipate a commercial launch in 2015."

The Sensus device, which won 510(k) clearance from the FDA in 2012, uses non-invasive electrical stimulation of sensory nerves to alleviate pain.

The OTC version of the device is in "late-stage development," the company said.

The news sent NURO shares surging 35.5% to $2.56 apiece today as of about 10:30 a.m.

Filed Under: Food & Drug Administration (FDA), News Well, Pain Management, Regulatory/Compliance Tagged With: Neurometrix

More recent news

  • Ambu wins FDA clearance for first single-use cysto-nephroscope
  • Tandem Diabetes Care pairs t:slim X2 pump with Abbott FreeStyle Libre 3 Plus in U.S.
  • Ypsomed, CamDiab to integrate Abbott dual glucose-ketone sensor into automated insulin delivery system
  • Johnson & Johnson MedTech launches new Volt plating systems for radius, humerus
  • PharmaSens, SiBionics collab on all-in-one insulin patch pump

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy