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Medicsight received a further request for Additional Information letter from the FDA relating to the Company's currently pending 510(k) pre-market notification for the ColonCAD.

Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. , and an 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 January 5, 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 June 21, 2010."

Source: Medicsight

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