Additional Information request from FDA
January 26 2010 - 9:25AM
UK Regulatory
TIDMMDST
RNS Number : 1478G
Medicsight Plc
26 January 2010
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| Press Release | 26 January 2010 |
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Medicsight PLC
("Medicsight" or "the Company")
Additional Information request for FDA 510(k) Clearance of
ColonCAD software
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 on 5 January 2010 it received a
further request for Additional Information (AI) letter from the US Food and Drug
Administration (FDA) relating to the Company's currently pending 510(k)
pre-market notification for the ColonCAD API 3.1 product.
The FDA previously issued an AI letter to the Company in December, 2008
requesting clarification of the intended use of the product, to which the
Company responded. In the most recent AI letter the FDA has requested further
technical details regarding the clinical trials and data analyses undertaken to
support clearance of the product.
FDA 510(k) submissions for Class 2 devices such as the current ColonCAD API 3.1
submission are necessarily complex and require the sponsor company to provide a
great deal of information relating to the design, manufacture and validation of
the product. It is not unusual for a second AI request to be received by a
company in order for the FDA to gain all the information they require in order
to assess a device. However, the FDA's 510(k) process is typically restricted to
two AI letters.
Allan Rowley, CEO of Medicsight, said: "We are working expediently with our
clinical and statistical advisors and the FDA to prepare the requested
information and expect to respond fully to the FDA before the deadline of 21
June 2010."
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For further information:
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| Medicsight PLC | www.medicsight.com |
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| Allan J Rowley | +44 (0)20 7605 7950 |
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| Daniel Stewart & Company PLC | |
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| Simon Leathers / Emma Earl | +44 (0) 20 7776 6550 |
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Media enquiries:
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| Abchurch Communications | +44 (0) 20 7398 7700 |
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| Heather Salmond / Simone Elviss | +44 (0) 20 7398 7728 |
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| simone.elviss@abchurch-group.com | www.abchurch-group.com |
+-----------------------------------------------+------------------------+
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 developed 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
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