• 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 » FDA slams Sironis for running unapproved trial

FDA slams Sironis for running unapproved trial

September 23, 2015 By Brad Perriello

Sironis, FDAThe FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau.

In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of clinical trial regulations, saying the company failed to ask for or won an investigational device exemption for the trial.

“Your firm began an investigation of a significant risk device on November 15, 2012, and failed to submit an IDE application to FDA. On December 27, 2013, your firm published findings in a medical journal from a study in which your unapproved device was used. According to your records and the letter to FDA from the University of California, Irvine Office of the Vice Chancellor for Research, dated August 27, 2014, the clinical sites had enrolled 66 subjects,” the FDA said in the warning letter. “Your failure to obtain FDA approval of an IDE prior to subject enrollment may have placed study subjects at increased risk of harm. Without FDA approval, the study lacked the regulatory oversight necessary for the protection of the public health and safety.

“Please do not conduct any further investigations of your device until you have obtained the appropriate FDA approval,” the FDA wrote.

The agency also said Sironis failed to inform an institutional review board about changes to the trial, failed to adequately describe the risks of the trial, and didn’t reveal the existence of alternative treatments as required.

“If you plan to continue clinical research with your device, an approved IDE is needed. No further clinical research may take place with this device until FDA approval of an IDE takes place,” the FDA said.

Filed Under: Clinical Trials, Food & Drug Administration (FDA) Tagged With: Sironis, Warning Letter

More recent news

  • Johnson & Johnson MedTech launches new Volt plating systems for radius, humerus
  • PharmaSens, SiBionics collab on all-in-one insulin patch pump
  • Beta Bionics to pair iLet automated insulin delivery system with Abbott’s dual glucose-ketone sensor
  • Anaconda Biomed wins CE mark for funnel catheter
  • FDA approves Neuspera neuromod for urinary incontinence

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