• 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 » iCAD wins FDA nod for computer-aided detection in virtual colonoscopies

iCAD wins FDA nod for computer-aided detection in virtual colonoscopies

August 5, 2010 By MassDevice staff

ICAD logo

Federal regulators cleared a new device for U.S. sales that produces three-dimensional images of the colon, specifically identifying polyps and other suspicious tissue that can be an early sign of cancer.

Nashua, N.H.-based iCAD Inc. (NSDQ:ICAD) developed the system, called the VeraLook, and already markets similar computer-aided detection equipment for breast and prostate cancers.

The Veralook had previously been approved for sale in Europe and Canada and 510(k) clearance by the U.S. Food & Drug Administration has been quietly anticipated for some time inside the company.

Still, iCAD executives were more than happy on Wednesday to tout VeraLook’s attributes, saying it will help doctors better intepret Computed Tomography Colonoscopy images while the non-invasive nature of virtual colonoscopies is working to convince more people to get screened.

“Our technology has become an important tool in helping radiologists find colon cancers earlier and with greater confidence,” iCAD CEO Ken Ferry said in a prepared statement announcing FDA clearance. “More than 40 million individuals who are eligible for colon cancer screening do not undergo any screening at all. Virtual colonoscopy may prompt a greater number of people to have this potentially life-saving test.”

As part of its 510(k) application, iCAD submitted results from a clinical trial indicating more than two-thirds of the CAD-enabled CT colonoscopy readers were more accurate than unassisted readers. CAD-assisted colonoscopies also were 5 percent more likely to detect polyps 6 millimeters or more in size, the study found.

The VeraLook algorhithms automatically identify polyps in images produced during virtual colonoscopies. A typical exam often contains between 1,200 to 1,500 images and VeraLook can find potential polyps that may not have seen in initial reviews.

“Computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage,” said Dr. Abraham Dachman, lead researcher for the clinical trial and a professor of radiology at the University of Chicago.

Although the company has not yet set a firm date for a U.S. launch, Veralook will likely be offered as part of third-party display workstations and from picture archiving and communication systems vendors. iCad said virtual colonoscopy currently is included under colon cancer screening guidelines developed by the American Cancer Society and in effect in 22 states and the District of Columbia.

Reimbursement for CTC screening procedures also is available from many U.S. private insurers, the company said.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: Colonoscopy, iCad Inc.

More recent news

  • Neuronetics names Steven Pfanstiel chief financial officer
  • Medtronic to distribute Future Medical’s peripheral guidewires
  • AtriCure completes enrollment in stroke prevention trial
  • GT Medical raises $53M to support brain tumor treatment
  • Imperative Care, Proximie partner to develop surgical robot to treat stroke

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