• 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

Acclarent Inc.

Integra LifeSciences completes acquisition of J&J’s Acclarent

April 2, 2024 By Sean Whooley

Integra LifeSciences announced that it completed its previously announced acquisition of Acclarent from Johnson & Johnson MedTech . Princeton, New Jersey-based Integra struck a deal with J&J to acquire Acclarent for $275 million upfront at the end of 2023. The deal also includes an additional $5 million upon the achievement of regulatory milestones. Acclarent, part […]

Filed Under: Business/Financial News, Featured, Mergers & Acquisitions, Otolaryngology/Ear, Nose & Throat (ENT), Wall Street Beat Tagged With: Acclarent Inc., Integra LifeSciences, Johnson & Johnson, Johnson & Johnson MedTech

J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system

December 21, 2023 By Sean Whooley

Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system. While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle […]

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

Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech

December 13, 2023 By Sean Whooley

Integra LifeSciences announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal […]

Filed Under: Business/Financial News, Featured, Mergers & Acquisitions, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Wall Street Beat Tagged With: Acclarent Inc., Ethicon, Integra LifeSciences, Johnson & Johnson, Johnson & Johnson MedTech

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

August 4, 2022 By Chris Newmarker

Johnson & 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 […]

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

DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

June 3, 2021 By Tom Salemi

Dr. Josh Makower quite possibly invented modern-day medtech innovation. In this interview, Makower shares his earliest inventions — kind of mind-blowing — and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this […]

Filed Under: Business/Financial News, Device Talks Podcasts, Featured, Special Content Tagged With: Acclarent Inc., DeviceTalks Weekly, iRhythm Technologies Inc., Medtronic, New Enterprise Associates, Rapid Medical, Stanford Biodesign

Ex-Acclarent execs fined $1.5M in off-label marketing case

January 14, 2021 By Chris Newmarker

There will be no prison time for the two former Acclarent executives convicted of federal misdemeanor charges related to marketing a sinus balloon catheter for unapproved uses. Former Acclarent CEO William Facteau will instead pay a $1 million fine, and the company’s ex-sales VP Patrick Fabian will pay $500,000, according to the sentence handed down […]

Filed Under: Featured, Food & Drug Administration (FDA), Legal News, Regulatory/Compliance Tagged With: Acclarent Inc., Johnson & Johnson

J&J’s Acclarent launches TruDi ENT nav system

May 3, 2018 By Fink Densford

Johnson & Johnson‘s (NYSE:JNJ) Acclarent said late last month it launched the TruDi real-time, three-dimensional navigation system designed for ENT procedures. Acclarent said that the first commercial procedures were performed with the device on April 16, after having previously won FDA 510(k) clearance. The TruDi system is an electromagnetic image-guided navigation system designed for endoscopic sinus […]

Filed Under: Business/Financial News, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Acclarent Inc., Johnson and Johnson

Ethicon, JNJ escape Acclarent whistleblower’s retaliation suit

September 21, 2017 By Fink Densford

Allegations from a former Acclarent sales rep claiming she was fired for submitting a false claims report were kept alive this week by a Massachusetts magistrate judge, but the same allegations against Acclarent parent companies Johnson & Johnson (NYSE:JNJ) and Ethicon were thrown out, according to a Law360 report. The former sales rep Melanie Lokosky claimed […]

Filed Under: Legal News Tagged With: Acclarent Inc., Ethicon, Johnson and Johnson

FDA puts Acclarent’s Aera Eustachian tube balloon in Class II

October 24, 2016 By Fink Densford

The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and […]

Filed Under: Catheters, Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Acclarent Inc.

Big Pharma urges acquittal for ex-Acclarent execs

September 23, 2016 By Sarah Faulkner

Pharmaceutical giants including Bayer (ETR:BAYN) and Pfizer (NYSE:PFE) filed a motion backing ex-Acclarent executives William Facteau and Patrick Fabian, urging the Massachusetts federal court to acquit them of their misdemeanor charges. Former Acclarent CEO Facteau and ex-sales vice president Fabian were convicted in July on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into […]

Filed Under: Food & Drug Administration (FDA), Legal News Tagged With: Acclarent Inc., Medical Information Working Group

Acclarent wins FDA nod for Aera Eustachian tube balloon

September 16, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said today that it won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system, designed to treat persistent Eustachian tube dysfunction. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the […]

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

  • Page 1
  • Page 2
  • Go to Next Page »

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