Navigation Links
CardioGenics to File for 510K Clearance With the United States Food and Drug Administration by Q4 2011
Date:2/3/2011

MISSISSAUGA, Ontario, Feb. 3, 2011 /PRNewswire/ -- CardioGenics Holdings Inc. (CGNH.OB) announced today final plans for testing of its QL Care™ (QLCA) Analyzer. The data that will be collected from the testing at 4 hospitals in North America will be used as a key component of the Company's 510K application with the United States Food and Drug Administration. The 510K application will allow the FDA to determine whether the QLCA is equivalent to another device that is currently approved by the FDA for commercialization.  Upon approval of the application, CardioGenics will begin marketing the QLCA throughout the United States.

The Company has determined that it will use the Siemens ADVIA Centaur Analyzer and its related Troponin-I test as the reference standard for its clinical testing. CardioGenics has already identified four hospitals that use the Siemens ADVIA Centaur and will obtain approval from these hospitals to conduct comparative clinical testing of its QL Care™ Analyzer and Troponin-I test at their sites. The goal of this comparative testing is to confirm that the results from the CardioGenics QL Care™ Analyzers and the Siemens ADVIA Centaur systems are equivalent. CardioGenics expects to begin enrolling patients in this comparative trial upon approval of the Institutional Review Boards, which approvals it expects to receive by May 2011. The comparative trials will take approximately 45 days to complete.

Upon successful completion of clinical confirmation, the Company will then finalize protocols and commence trials for the FDA application for approval of its QL Care™ Analyzer and Troponin-I test. This final testing is expected to start during early Q3 2011 and complete two months later.

Yahia Gawad, MD, Chief Executive Officer of CardioGenics Holdings Inc. said, "Over the past few months, we have completed development of the QL Care™ Analyzer. We have solved many of the technological challenges that
'/>"/>

SOURCE CardioGenics Holdings Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. CardioGenics Holdings Inc. Provides Update on FINRA Submission Regarding Name Change
2. CardioGenics Holdings Inc. Announces Letter to Shareholders
3. CardioGenics Announces Completion of Cartridge Design for QL Care Analyzer
4. CardioGenics Holdings Inc. Featured in Medical Device Daily
5. Dr. Yahia Gawad, CEO of CardioGenics Holdings, Inc., Interviewed in MedTech Executive
6. CardioGenics Provides Update on Agreement with Merck Chimie for Its Silver Coated Paramagnetic Beads
7. CardioGenics Announces Further Update Regarding Status of Merck Agreement
8. CardioGenics Announces Lock-Up Agreement with Dr. Yahia Gawad
9. CardioGenics to be Spotlighted in Three Publications During Month of April
10. CardioGenics Announces Update Regarding Status of Merck Agreement
11. CardioGenics Announces Reverse Stock Split
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... , Dec. 17, 2014  Beamz Interactive, ... interactive music products, today announced that it has ... leading manufacturer and supplier of innovative prosthetic, orthotic ... As part of the agreement, RSL Steeper will ... solution specifically configured for use within UK residential ...
(Date:12/17/2014)... ANGELES , Dec. 17, 2014  ImmunoCellular ... the US Patent and Trademark Office (USPTO) has ... ICT-107, a dendritic cell-based immunotherapeutic vaccine targeting six ... The claims of US Patent No. 8,871,211, which ... neural cancer by administering a dendritic cell composition ...
(Date:12/17/2014)... Mass. , Dec. 17, 2014  RXi ... biotechnology company focused on discovering, developing and commercializing ... RNA-targeted technologies, today announced completion of enrollment in its ... from the 3-month observations confirmed the 1-month findings ... Logo - http://photos.prnewswire.com/prnh/20130917/NE80755LOGO ...
Breaking Medicine Technology:Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5
... NEW YORK, March 20, 2012  Faruqi & Faruqi, ... investigating potential securities fraud at ZELTIQ Aesthetics, Inc. ... (Logo: http://photos.prnewswire.com/prnh/20120119/MM38856LOGO  ) Faruqi ... misled investors by failing to disclose material information ...
... WASHINGTON, March 20, 2012  At a public event ... Fight AIDS, Tuberculosis and Malaria and Friends of ... spotlighted the contributions of public-private partnerships to the ... delivery, to supplying much-needed resources, to mobilizing consumer ...
Cached Medicine Technology:Faruqi & Faruqi, LLP Announces Investigation of ZELTIQ Aesthetics, Inc. 2Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 2Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 3Global Fund Celebrates Efforts of Partners Chevron, The Coca-Cola Company, (RED) and PEPFAR at Capitol Hill Event 4
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... and vision assessments provided by InfantSEE(R) ProgramCHARLESTON, W.Va., ... of children with eye and vision problems across ... appointments to no-cost, comprehensive eye and vision assessments ... age through InfantSEE(R). InfantSEE(R), a public health program ...
... New York, N.Y. April 28, 2009 Peripheral arterial disease ... plaque and blood supply to the legs is reduced, affects eight ... because it can limit the ability to walk and exercise, it ... increases the chance of having a heart attack or stroke. Coronary ...
... text to speech instantly converts Word, PDF, PowerPoint, Excel and Web ... ... NJ (PRWEB) April 28, 2009 -- iSpeech.org, text to speech software ... to anyone using the Box.net platform. The integration allows Box customers ...
... Health Care ReformWASHINGTON, April 28 Private-sector strategies ... an essential component of comprehensive health care reform, ... AHIP hosted a press conference today to highlight ... to reward quality and spur improvement."There is widespread ...
... membership organizations today released Guidelines for Patient Centered ... the American Academy of Family Physicians (AAFP), the ... of Physicians (ACP) and the American Osteopathic Association ... pediatrician, family physician, internist and osteopathic physician members ...
... studies have shown that depression is associated with an increased ... clear. , Now, researchers at Rush University Medical Center have ... fat, the kind of fat packed between internal organs at ... risk of cardiovascular disease and diabetes. , The study is ...
Cached Medicine News:Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 2Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 3Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 4Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 5Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 6Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 7Health News:West Virginia Optometrists Partner With Sens. Byrd and Rockefeller, U.S. House Leaders in Improving Infant Eye and Vision Care 8Health News:Arterial disease of the leg frequently overlooked in patients with heart disease 2Health News:iSpeech.org Makes Box.net Talk Aloud 2Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 2Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 3Health News:New Health Plan Payment Models Are Improving Patient Quality and Safety 4Health News:Guidelines for medical home demonstrations released by major physician groups 2Health News:Guidelines for medical home demonstrations released by major physician groups 3Health News:Depression linked with accumulation of visceral fat 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: