• 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 » J&J’s Acclarent wins FDA clearance for navigated shaver blade for ENT procedures

J&J’s Acclarent wins FDA clearance for navigated shaver blade for ENT procedures

August 4, 2022 By Chris Newmarker

Logo of Johnson & Johnson MedTech's Acclarent businessJohnson & Johnson MedTech’s Acclarent business announced FDA 510(k) clearance for its TruDi shaver blade and its advanced navigation features.

In a news release posted yesterday, Acclarent described TruDI as a single-use electromagnetically navigated blade. It’s used with the company’s Bien-Air S120 shaver for the incision and removal of soft and hard tissue or bone in ENT, maxillofacial surgery, head and neck, and ENT skull base surgery.

The TruDi shaver blade is navigable. It has distal tip sensor integration, enabling the display of the blade’s position and opening on the TruDi navigation system.

“When performing endoscopic sinus procedures, every millimeter counts, so a navigable shaver blade connected to a sophisticated mapping system that provides real-time visualization of the blade location helps me know where I am, where my trainees are, and where we are going during surgery,” said Dr. C.S. Ebert Jr. professor at the Department of Otolaryngology – Head & Neck Surgery at the University of North Carolina – Chapel Hill. “

“The TruDi Shaver Blade represents a technological innovation that can enable more consistent and accurate procedures,” Ebert said in the news release. “These features along with FAM mapping of the powered instruments, the anatomy segmentation with alerts, and 3D views with a true-to-size icon changes the paradigm in powered instrument navigation.”

Acclarent President Jeff Hopkins described the clearance as an “important milestone in Acclarent’s journey toward our mission to change the ENT landscape through innovative technology and help physicians deliver improved patient outcomes.”

The TruDi shaver blade includes a variety of configurations with multiple angles. The idea is to address different patient anatomies.

The blade is intended for use with the Bien Air (BA) S120 shaving handpiece, the TruDi navigation system and the Bien Air OsseoDuo console. The TruDi shave blade interacts with all of TruDi’s advanced navigation features.

Filed Under: 510(k), Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Surgical Tagged With: Acclarent Inc., Johnson & Johnson

More recent news

  • EBR Systems raises $36.1M for leadless pacing tech
  • The biggest cardiovascular tech news out of EuroPCR 2025
  • CardiaWave has positive 12-month Valvosoft results
  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Medtronic has new Cardiovascular, CST leaders after longtime exec departs

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email 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