• 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 » Axonics files FDA PMA supplement for its non-rechargeable SNM system

Axonics files FDA PMA supplement for its non-rechargeable SNM system

June 25, 2021 By Sean Whooley

Axonics Modulation TechnologiesAxonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system.

Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release.

The company designed its new non-rechargeable SNM system to replicate the key features of its currently marketed and FDA-approved rechargeable SNM system. The new version includes a primary cell battery with an expected life of at least 10 years with standard constant-current stimulation parameters for longevity.

Axonics’ INS is 11 cubic centimeters and has compatibility with full-body MRIs with 1.5T and 3.0T scanners, while patients can remotely control it with an intuitive, recharge-free key fob featuring SmartMRI technology.

The company expects to begin shipping the new system to customers upon FDA approval, which is anticipated to come during the first half of 2022.

“Since the company’s founding, we have focused on developing best-in-class, patient-centric SNM solutions. Our rechargeable system introduced innovations to the SNM category that clinicians and patients had been requesting for years – longevity in the body, MRI compatibility, a miniaturized implant and a fuss-free patient remote control that is easy for patients to use,” Axonics CEO Raymond W. Cohen said in the release. “Our new non-rechargeable system is similarly groundbreaking – a relatively small and thin INS with an expected life in the body that is more than double the competitor’s non-rechargeable device. We are confident that the introduction of our non-rechargeable device will continue to drive market expansion and advance Axonics on its path to SNM market leadership.”

Filed Under: Featured, Food & Drug Administration (FDA), Implants, Neurological, Neuromodulation/Neurostimulation, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Axonics Modulation Technologies, FDA

More recent news

  • Zynex submits laser pulse oximeter to FDA
  • Roche invests $550M to make Indianapolis a CGM manufacturing hub
  • Product liability lawsuits target Medtronic, Boston Scientific spinal cord stim tech
  • GE HealthCare launches new MRI scanner
  • HistoSonics earns first major reimbursement win for non-invasive histotripsy

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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