Navigation Links
Mitsubishi Chemical Medience Corporation Receives 510(k) Clearance for PATHFAST® cTnI-II (cardiac Troponin I) Test in U.S.
Date:6/13/2011

TOKYO, June 14, 2011 /PRNewswire/ -- Mitsubishi Chemical Medience Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) premarketing notification clearance to the PATHFAST® cTnI-II (cardiac Troponin I) diagnostic test, clearing the way for its sale in the United States. The test is designed to be used with the PATHFAST analysis system, a unique, self-contained, bench-top chemi-luminescence immunoanalyzer that rapidly measures concentrations of emergency biomarkers from a single whole blood sample.

The PATHFAST cTnI-II test determines the quantity of cardiac troponin I, a protein that is integral to cardiac muscle contraction, which is elevated in the bloodstream after damage to the myocardium (the middle and thickest layer of the heart wall).(1),(2) Due to its absolute coronary specificity and high sensitivity, cardiac troponin I is considered the preferred biomarker for diagnosing cardiac muscle damage, particularly following a heart attack.

"We are pleased that the FDA has recognized the utility of the PATHFAST system for measuring levels of cardiac troponin I in whole blood, and are confident the test will be widely accepted in the U.S. market, in accordance with international guidelines," commented Dr. Toshihiko Yoshitomi, President and CEO of Mitsubishi Chemical Medience. "Today's news is also an important step in supporting our ongoing negotiations to secure a strategic distribution partnership to launch the PATHFAST product line in the U.S. by early 2012."  

The 510(k) clearance of the PATHFAST cTnI-II test completes the cardiovascular product line of the PATHFAST analysis system, which also includes tests to determine quantities of N-terminal pro brain natriuretic peptide (NT-proBNP), D-Dimer, myoglobin, creatinine kinase (CK)-MB, and high-sensitivity C-reactive protein (hsCRP). With its whole blood use capability, the PATHFAST system eliminates the need for centrifugation of the sp
'/>"/>

SOURCE Mitsubishi Chemical Medience Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Anaphore Enters R&D Partnership with Mitsubishi Tanabe Pharma to Develop and Commercialize Novel Protein Pharmaceuticals for Autoimmune Disorders
2. Reportlinker Adds The Global Pharmaceutical Fine Chemicals Market Outlook to 2015
3. AMPAC Fine Chemicals Adds New Capabilities for Clinical Programs
4. Ampac Fine Chemicals President Aslam Malik Joins SOCMAs Board of Governors; Industry Veteran Adds Significant Experience to Board
5. FDA Approves Pediatric Use of Chemical Poisoning Treatment
6. Dr. Harry J. Guttman, Esq. Invited Speaker at 2010 Central Regional Meeting of the American Chemical Society
7. Multiple Chemical Sensitivities Are Real
8. ChemImages Raman Chemical Imaging Used for Ingredient-Specific Particle Sizing for Inhalation Product Development
9. AMPAC Fine Chemicals Partners With Inabata & Co., Ltd. of Japan
10. New ionator EXP(TM) and ionator HOM(TM) Kill Swine Flu Without Use of Chemicals
11. Sigma-Aldrich Becomes the Sole U.S. and Canada Distributor of Kromasil(R) HPLC Columns Through Agreement With Eka Chemicals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)... China Biologic Products, Inc. (NASDAQ: CBPO, ... integrated plasma-based biopharmaceutical company in China ... Guizhou Taibang Biological Products Co., Ltd. ("Guizhou Taibang") ... with Xinjiang Deyuan Bioengineering Co., Ltd. ("Xinjiang Deyuan") ... Taibang to source no less than 500 tonnes ...
(Date:9/2/2015)... Sept. 2, 2015  MGC Diagnostics Corporation (NasdaqCM: MGCD), ... call to discuss its financial results for the third ... call will be at 4:30 p.m. ET on Thursday, ... for the third quarter of fiscal 2015 after the ... Participants can dial (877) 317-6789 or (412) 317-6789 ...
(Date:9/2/2015)... , Sept. 2, 2015 BioPharmX Corporation (NYSE MKT: ... Jim Pekarsky , chief executive officer and co-founder of ... Global Investment Conference taking place, September 8-10, 2015 at The ... Mr. Pekarsky is scheduled to present on September 10 ... (2 nd floor). A live webcast of ...
Breaking Medicine Technology:China Biologic Enters into Strategic Collaboration Agreement to Source Raw Materials 2China Biologic Enters into Strategic Collaboration Agreement to Source Raw Materials 3China Biologic Enters into Strategic Collaboration Agreement to Source Raw Materials 4China Biologic Enters into Strategic Collaboration Agreement to Source Raw Materials 5MGC Diagnostics Corporation to Report Third Quarter Fiscal 2015 Financial Results on Thursday, September 10, 2015 2
... Mass., May 10, 2011 In an on-going effort to ... Intelligence (CBI) announced today that the company will donate $5,200 ... conjunction with its annual Thanksgiving card issued to loyal conference ... card offering exclusive savings toward a future conference of choice. ...
... Reportlinker.com announces that a new market research ... Medical Imaging Reports Bundle ... Report Description The Medical Imaging ... at a 15% discount off the individual reports being purchased ...
Cached Medicine Technology:The Center for Business Intelligence Donates More than $5,000 to the Greater Boston Food Bank 2Reportlinker Adds Medical Imaging Reports Bundle 2Reportlinker Adds Medical Imaging Reports Bundle 3Reportlinker Adds Medical Imaging Reports Bundle 4Reportlinker Adds Medical Imaging Reports Bundle 5Reportlinker Adds Medical Imaging Reports Bundle 6Reportlinker Adds Medical Imaging Reports Bundle 7
(Date:9/2/2015)... , ... September 02, 2015 , ... Ericson is a ... Education Director for HCPro and Associate Director of Education for the Association for Clinical ... CDI and ICD-10 for CDI Boot Camps. She serves as a CDI subject matter ...
(Date:9/2/2015)... ... ... Every year at this time, students prepare to go back to school. ... the academic workload confronting them. They just don’t have the skills needed to do ... students how to study. , “Bankers bank. Salesmen sell. Teachers teach. The job of ...
(Date:9/2/2015)... City, KS (PRWEB) , ... September 02, 2015 , ... ... opened its newest office in Kansas – its Johnson County location. Amada ... in healthcare. Mike has a registered nurse background and spent over 20 years in ...
(Date:9/2/2015)... North Las Vegas, NV (PRWEB) , ... September ... ... in Las Vegas and Fort Lauderdale, CENTURION SERVICE GROUP is internationally known as ... the largest medical auction house in the world, selling more than 100,000 pieces ...
(Date:9/2/2015)... ... 02, 2015 , ... On September 9, 2015, over 27,000 people from all ... single-company convention to date for the state of Utah. , “We are thrilled with ... states David Stirling, doTERRA CEO. “One of the most exciting elements of our convention ...
Breaking Medicine News(10 mins):Health News:ezDI Names Noted CDI Educator Cheryl Ericson as Company’s Clinical Documentation Manager 2Health News:ezDI Names Noted CDI Educator Cheryl Ericson as Company’s Clinical Documentation Manager 3Health News:ezDI Names Noted CDI Educator Cheryl Ericson as Company’s Clinical Documentation Manager 4Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 2Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 3Health News:Amada Senior Care Expands to Greater Kansas City 2Health News:Over 1800 Lots of Surplus Used Medical Equipment 2Health News:Over 1800 Lots of Surplus Used Medical Equipment 3Health News:doTERRA to Host the Largest Single-Company Convention in the State of Utah 2
... Dec. 1 The Kerlan Jobe Orthopaedic Clinic, a sports ... United States $3 million to settle allegations that it received ... , The settlement resolves allegations ... of stock option grants, donations to the Kerlan Jobe Foundation, ...
... A scientist who broadened the understanding of how we experience ... -- has won the 2010 University of Louisville Grawemeyer Award ... University in Montreal, was selected for the award from among ... of injury but instead in their brain through a pathway ...
... more likely, British study finds , TUESDAY, Dec. 1 (HealthDay ... to deliver a very preterm baby than more affluent women, ... British study shows. , The University of Leicester research team ... the association between economic status and preterm birth. , For ...
... on computed tomography (CT) imaging of changes in tumors ... bevacizumab may have the potential to predict overall survival, ... of JAMA . The addition of ... with improved survival in patients with stage IV colorectal ...
... ... ... largest national HIV non-profit organizations, is changing its name to HealthHIV and launching a new ... promote the organization’s new vision and expanded capabilities and reach. , , , , ,“HealthHIV ...
... With employee benefit choices becoming more complex, a growing ... during open enrollment season, according to a new survey by ... employers who offer these tools believe they lead employees to ... survey, 45 percent of companies offered employees self-service decision tools ...
Cached Medicine News:Health News:Los Angeles' Kerlan Jobe Orthopaedic Clinic Pays $3 Million to Settle Kickback Allegations 2Health News:Scientist Who Helps Explain Pain Wins Grawemeyer Award 2Health News:More Preemies Born Among the Poor 2Health News:Criteria based on CT imaging after chemotherapy may help predict survival 2Health News:National HIV Non-Profit Announces New Name 2Health News:Employers Plan to Increase Use of Self-Service Decision-Making Technology For Open Enrollment, Watson Wyatt Survey Finds 2Health News:Employers Plan to Increase Use of Self-Service Decision-Making Technology For Open Enrollment, Watson Wyatt Survey Finds 3
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
... AEM Laparoscopic Instruments incorporate a layered design ... shielded and monitored to prevent stray electrosurgical ... caused by insulation failure or capacitive coupling; ... shield built into all AEM Instruments provides ...
... Instruments incorporate a layered design unique in ... monitored to prevent stray electrosurgical burns along ... insulation failure or capacitive coupling; a well-documented ... into all AEM Instruments provides a neutral ...
Medicine Products: