FDA Additional Information request
January 20 2009 - 2:00AM
UK Regulatory
TIDMMDST
RNS Number : 8853L
Medicsight Plc
20 January 2009
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| Press Release | 20 January 2009 |
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Medicsight PLC
("Medicsight" or "the Company")
Additional Information request for FDA 510(k) Clearance
Medicsight PLC (AIM: MDST), industry leader in the development of Computer-Aided
Detection (CAD) and image analysis software which assists radiologists in the
early detection of disease, announces that it has received a request for
Additional Information (AI) letter from the US Food and Drug Administration
(FDA). This request is in regard to the 510(k) pre-market notification for the
ColonCAD API 3.1 product. The FDA has requested clarification of the intended
use of the product. Medicsight is collating the information required, will
continue discussions with the FDA and will provide a response to the agency in
due course.
- Ends -
For further information:
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| Medicsight PLC | www.medicsight.com |
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| David Sumner | +44 (0)20 7605 7950 |
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| Nomura Code | |
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| Juliet Thompson | +44 (0) 20 7776 1204 |
| Jonathan Senior | +44 (0) 20 7776 1219 |
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Media enquiries:
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| Abchurch | |
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| Heather Salmond / Stephanie | +44 (0) 20 7398 7700 |
| Cuthbert / Simone Alves | |
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| stephanie.cuthbert@abchurch-group.com | www.abchurch-group.com |
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Notes to editors
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 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(TM) and LungCAD(TM) 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 2000 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 can
be 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. In addition to supporting individual
radiologists CAD also has the potential to help standardise CT interpretation
across both individuals and institutions thereby supporting population based
screening programmes.
About Medicsight's CAD software
Medicsight's ColonCAD(TM) and LungCAD(TM) 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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