Navigation Links
Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance
Date:1/26/2010

NEW YORK, Jan. 26 /PRNewswire-FirstCall/ -- Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. (NYSE Amex: MGT), 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."

About MGT Capital Investments, Inc.

MGT Capital Investments, Inc. is a technology holding company that focuses on investments in the global healthcare information technology market. The Company has two subsidiaries, Medicsight PLC and Medicexchange PLC.

Medicsight PLC (AIM: MDST) 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 computerized tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyze 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 visualization workstations of several industry-leading imaging equipment partners.

Medicexchange PLC provides medical imaging professionals with a global web portal containing an online sales, jobs and information channel for diagnostic, treatment and surgery planning solutions. This combined with a variety of relevant clinical papers, training materials and content gives these professionals access to information and products that they otherwise would have difficulty accessing.

Additional information can be found at www.mgtci.com.

All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.

SOURCE MGT Capital Investments, Inc.; Medicsight PLC

RELATED LINKS
http://www.mgtci.com

'/>"/>

SOURCE MGT Capital Investments, Inc.; Medicsight PLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ACRIN Study Endorses Virtual Colonoscopy - Validation for Colon CAD Software Maker Medicsight plc
2. Novo Nordisks Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes
3. KV Pharmaceutical Receives Report From Inspector of Elections Certifying Votes to Approve Appointment of Director
4. Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
5. Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Ofloxacin and Fleroxacin
6. GeneGo Receives SBIR Grant
7. WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor(TM) VAD
8. VIA Pharmaceuticals Receives Delisting Notification From NASDAQ
9. KV Pharmaceutical Receives Permission from NYSE for its Securities to Continue Trading on the NYSE until March 31, 2010
10. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
11. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/28/2017)... 28, 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), ... call and webcast on Friday, November 3, 2017, beginning ... ending at approximately 8:30 a.m. (CDT) / 9:30 a.m. ... 2017 financial performance and guidance for 2018, Hill-Rom executives ... enhance operational performance, and long-range financial outlook through 2020. ...
(Date:9/25/2017)... PROVIDENCE, R.I. , Sept. 25, 2017 /PRNewswire/ ... immunogenicity assessment, vaccine design, and immune-engineering today announced ... focused on the development of personalized therapeutic cancer ... and has provided exclusive access to enabling technologies ... MSc Eng., MBA will lead EpiVax Oncology as ...
(Date:9/19/2017)...   ZirMed Inc ., a recognized leader in cloud-based ... has been ranked #1 by its users for the seventh ... User Survey. ZirMed was recognized as the top-ranked end-to-end revenue ... centers over 200 beds and holds one of the longest ... history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... Ky. (PRWEB) , ... October 13, 2017 , ... The ... MPH to become its next President and Chief Executive Officer, succeeding Dr. James C. ... CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end of ...
(Date:10/13/2017)... ... ... PurhealthRX , a leading Health and Nutrition Company, is announcing the ... spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the amount ... into liquid products, while reducing costs to end users. , The team of researchers ...
(Date:10/13/2017)... ... 2017 , ... Lori R. Somekh, founder of the Law Office of ... elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain ... to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that covers ... companies have a waiver for care if the client has a cognitive impairment diagnosis. ... pays for care, is often waived, so the benefits from their insurance start immediately,” ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
Breaking Medicine News(10 mins):