• 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 » Ethicon Endo-Surgery wins review of PMA denial

Ethicon Endo-Surgery wins review of PMA denial

November 11, 2010 By MassDevice staff

Ethicon Endo-Surgery logo

Ethicon Endo-Surgery Inc.’s Sedasys System was granted its appeal by the commissioner’s office of the Food & Drug Administration.

The FDA’s Center for Devices and Radiological Health initially denied the company’s pre-market approval application for the gastroenterology procedure sedation system. The appeal means the FDA will appoint a new advisory committee and hold a public hearing on the device, with a final decision falling to FDA commissioner Dr. Margaret Hamburg.

"We look forward to the new Independent Advisory Panel review to reconsider our clinical trial data, which demonstrated the system is safe and effective," company group chairwoman Karen Licitra said in prepared remarks. The Johnson & Johnson subsidiary (NYSE:JNJ) sent a letter to the FDA commissioner for the appeal last week.

Cincinnati-based Ethicon Endo-Surgery first filed a petition for reconsideration in March, after receiving its first non-approval notification from the CDRH, but the FDA’s medical device wing responded with another denial letter in October, according to the company. Appeal is a rarely used part of the pre-market approval application process that device and drug companies can pursue when one of the centers within FDA denies their product’s application.

Ethicon describes the Sedasys System as the “first-of-its-kind computer-assisted personalized [propofol] sedation system for colonoscopy and upper gastrointestinal procedures.” The device is designed to provide integrated patient monitoring with personalized drug delivery. The company said the device “would help reduce sedation-related risks associated with colonoscopies, improve the overall patient experience, and encourage more individuals to be screened for colon cancer, which kills more than 50,000 Americans each year.” The system has already received European CE Mark approval and Australian approval.

Filed Under: Business/Financial News, News Well Tagged With: Anesthesia, Ethicon, Gift Bans, Johnson and Johnson

More recent news

  • Autonomix picks up key nerve ablation catheter patent
  • Affluent Medical can move to pivotal phase of artificial urinary sphincter study
  • Globus Medical announces $500M share repurchase program
  • Cook Medical warns of issue with angiographic catheter
  • Virtuoso Surgical reports first cases with robotic endoscopy system, plans FDA IDE submission

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