Brazilian State Food and Drug Administration approval
Medicsight PLC (AIM: MDST), an industry leader in the development of Computer-Aided Detection (CAD) and image analysis software which assists in the early detection and diagnosis of disease, today announces that it has received approval from the Brazilian regulatory agency, Agencia Nacional de Vigilancia Sanitaria ("ANVISA"), for its ColonCAD™ software.
David Sumner, Chief Executive of Medicsight, commented: "This is another important milestone for Medicsight and our partners as we commercialise our technology globally. This regulatory approval in the dynamic Latin American market is another approval in a high growth BRIC market, following on from the Chinese State Food and Drug Administration approval announced in April."
Dr Stuart Taylor of University College Hospital, London, a principal investigator for Medicsight, commented: "The approval of Medicsight's ColonCAD™ software is great news for patients. It will also be a bonus for radiologists, whose workload is growing rapidly, both due to the rising prevalence of colorectal cancer and the advances in imaging technology which have led to a substantial increase in the amount of image data that must be reviewed for each patient scan. Medicsight's technology can help to ease this burden, potentially reducing human error and also providing a valuable tool, especially for less experienced readers, to interpret these complex scans.
"Medicsight's CAD software has been validated against one of the world's largest and most population diverse proprietary databases of verified CT scan data, making the software applicable to patients of many different nationalities."
Medicsight's ColonCAD™ computer-aided detection technology aims to assist radiologists in the detection of colorectal neoplasia (polyps) by automatically highlighting suspicious areas on CT colonography scan images. The software may also help radiologists detect potentially malignant tumours at an early stage when treatment is most likely to be successful.
For further information:
Medicsight PLC
David Sumner
Tel: +44 (0)20 7605 7950
www.medicsight.com
Nomura Code
Jonathan Senior
+44 (0) 20 7776 1219
Juliet Thompson
+44 (0) 20 7776 1204
Media enquiries:
Abchurch Communications
+44 (0) 20 7398 7700
Heather Salmond / Stephanie Cuthbert / Simone Alves
+44 (0) 20 7398 7704
+44 (0) 20 7398 7718
stephanie.cuthbert@abchurch-group.com
www.abchurch-group.com
Notes to editors
About Medicsight
Medicsight PLC is a UK-headquartered, research-driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. The CAD software automatically highlights suspicious areas on computerised tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyse potential disease and early indicators of disease. Medicsight's computer-aided detection (CAD) software has been validated using one of the world's largest and most population diverse databases of verified patient CT scan data. Medicsight's ColonCAD™ and LungCAD™ software products are seamlessly integrated with the advanced 3D visualisation workstations of several industry-leading imaging equipment partners.
About Computer-Aided Detection
With increasingly sophisticated radiological imaging hardware such as Multi-Detector CT scanners, radiologists are facing a growing challenge in the amount of detailed patient image data that they must review for each patient examination. Some CT scan examinations generate as many as 1000 images per patient. Review of this data by the radiologist is not only time-consuming but also prone to error due to reader fatigue. CAD software can help the reviewing radiologist by analysing the image data and automatically highlighting suspicious regions of interest for closer inspection. Without CAD software some potential abnormalities or areas of disease may be overlooked. This is critical for diagnosis and the management of patient outcomes as early detection of disease greatly increases the probability of successful treatment and a positive therapeutic outcome.
About Medicsight's CAD software
Medicsight's ColonCAD™ and LungCAD™ software use an advanced CAD algorithm to analyse CT scans of the colon and lung and automatically highlight suspicious areas that may be indicators of disease. CAD may highlight areas easily overlooked by the reviewing radiologist, such as small lesions or regions that are hidden from view behind folds in the colon or normal structures and surrounding tissue in the lung.
Both CAD products seamlessly integrate with the advanced 3D visualisation platforms of industry-leading imaging equipment partners. The integrated systems provide sophisticated image viewing capabilities, including 3D reconstructed image data, with the added advantage of demonstrating automatic CAD findings to assist clinical end users in the detection and analysis of disease. This allows clinical end users to perform either a 'second read', where CAD findings are displayed to the user after completion of an initial review of the CT scan data, or a 'concurrent read' where CAD findings are displayed during the user's initial review of the original CT scan images.
Since inception, Medicsight has developed close and lasting relationships with some of the world's foremost clinicians in product related areas. This provides the Company with a wealth of clinical expertise and dedicated clinical research to support ongoing product development. Medicsight also collaborates with a number of leading academic institutions and clinical research programmes worldwide to develop the Company's comprehensive database of population diverse verified patient CT scan data, thus allowing Medicsight's products to be validated to the highest possible standards.