News | November 18, 2008

Medicsight Seeks 510(k) Clearance for ColonCAD


November 18, 2008 - Medicsight PLC has submitted for a 510(k) Premarket Notification to the FDA for clearance to market its ColonCAD image analysis software throughout the U.S.

Colon CAD can assist radiologists in the detection of colonic lesions. Medicsight has completed a large multireader CT Colonography clinical trial involving the review of several hundred patient datasets to support the FDA submission. This study was led by Professor Steve Halligan of University College Hospital, London, and demonstrates the significant benefits of ColonCAD technology on radiologists’ diagnostic performance.

Medicsight has already received regulatory approval from to market ColonCAD throughout Europe, Canada, Australia, China and Brazil.

For more information: www.mgtci.com

Related Content

Image courtesy of Philips Healthcare

News | Clinical Trials | July 19, 2018
The use of computed tomography (CT) scans has increased dramatically over the last two decades. CT scans greatly...
CT Decision Instrument Reliably Guides Pediatric Blunt Trauma imaging Decisions

This is a four-site prospective observational cohort. Image courtesy of Kirsty Challen, B.Sc., MBCHB, MRES, Ph.D., Lancashire Teaching Hospitals, United Kingdom.

News | Clinical Decision Support | July 18, 2018
A new study finds The Pediatric NEXUS Head Computed Tomography (CT) Decision Instrument (DI) reliably identifies blunt...
Artificial Intelligence Provides Faster, Clearer MRI Scans

A new artificial-intelligence-based approach to image reconstruction, called AUTOMAP, yields higher quality images from less data, reducing radiation doses for CT and PET and shortening scan times for MRI. Shown here are MR images reconstructed from the same data with conventional approaches, at left, and AUTOMAP, at right. Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital

News | Artificial Intelligence | July 17, 2018
A research team with funding from the National Institute for Biomedical Imaging and Bioengineering (NIBIB) has...
Study Shows Biomarker Panel Boosts Lung Cancer Risk Assessment for Smokers
News | Lung Cancer | July 16, 2018
A four-protein biomarker blood test improves lung cancer risk assessment over existing guidelines that rely solely upon...
iSchemaView Brings RAPID Imaging Platform to Australia and New Zealand
News | Stroke | July 13, 2018
iSchemaView has signed Diagnostic Imaging Australia (DIA) to be the exclusive distributor for the RAPID cerebrovascular...
Zebra Medical Vision Announces FDA 510(k) Clearance of Coronary Calcium Algorithm
Technology | Computed Tomography (CT) | July 12, 2018
Zebra Medical Vision has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Coronary...
IAC Awards First CT Accreditation for a Mobile Stroke Unit
News | Computed Tomography (CT) | July 09, 2018
The Intersocietal Accreditation Commission (IAC) recently recognized the University of Tennessee Health Science Center...
HeartFlow Announces New Commercial Coverage With UnitedHealthcare
News | Computed Tomography (CT) | July 03, 2018
HeartFlow Inc. announced that UnitedHealthcare now covers the HeartFlow FFRct Analysis, extending access to their 45...
Peter Juodka, RT(CT) operates the 16-slice Siemens Somatom Scope CT scanner in the mobile stroke unit to assess stroke patients immediately at the call site.

Peter Juodka, RT(CT) operates the 16-slice Siemens Somatom Scope CT scanner in the mobile stroke unit to assess stroke patients immediately at the call site.

Feature | Computed Tomography (CT) | July 03, 2018 | By Jeff Zagoudis
Stroke is the fifth leading cause of death in the United States, responsible for more than 140,000 deaths in some of
Overlay Init