Navigation Links
PreMD Provides Update on 510(k) Application for PREVU(x) POC
Date:9/6/2007

TORONTO, Sept. 6 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced that it has received questions from the U.S. Food and Drug Administration (FDA) regarding its 510(k) application for an expanded regulatory claim for its POC skin cholesterol test. PreMD submitted the 510(k) application to the FDA in June 2007. The submission seeks to obtain broader clearance in the assessment of cardiovascular disease risk in individuals without known disease. PreMD believes the specific matters raised by the FDA are fully addressable and the Company plans to submit a response within the alloted timeline of 30 days.

"Receiving questions from the FDA is a common part of the regulatory process," said Brent Norton, president and chief executive officer of PreMD. "Based on our current information and analysis, we plan to provide the FDA with the information they requested within 30 days. We are confident that we are on the path towards expanded regulatory clearance."

About PreMD Inc.

PreMD Inc. is a leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. PreMD's cardiovascular products are branded as PREVU(x) Skin Cholesterol Test, to be marketed and distributed by AstraZeneca. The company's cancer tests include ColorectAlert(TM), LungAlert(TM) and a breast cancer test. PreMD's head office is located in Toronto, Ontario and its research and product development facility is at McMaster University in Hamilton, Ontario. For more information about PREVU(x), please visit http://www.prevu.com.

This press release contains forward-looking statements. These statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the succ
'/>"/>

SOURCE PreMD Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Acupuncture provides relief
2. Micro-camera provides new breast imaging technique
3. MicroRNA provides new insight into birth defects
4. Hormone therapy provides no heart benefit
5. Drug Spironolactone Provides Renal And Cardioprotection In Diabetic Patients
6. Neurobiology Provides Answers To Block Memory-Related Drug Cravings
7. Cholesterol provides immunity against infection by certain parasites
8. John Hopkins CGHH program provides Global Health education
9. Protein provides antioxidant protection to Neurons
10. London Hospital Provides Specialized Care For Pregnant Women
11. Study Provides Evidence That Obesity Leads To A More Aggressive Ovarian Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/24/2014)... Diego, California (PRWEB) November 24, 2014 Dr. ... San Diego Fertility Center, recently appeared on NBC to discuss ... option. Egg freezing has been trending in the news recently, ... this expensive procedure for women. , “[The companies] ... women who are on a career hot path.” Says Dr. ...
(Date:11/23/2014)... For the coming special Friday, Tidebuy, a famous wedding ... for many products, especially the beautiful colored wedding dresses ... with amazing discounts, up to 90% off. Don’t hesitate ... easy to buy colored wedding dresses in different sizes ... famous for delicate craftsmanship, elegant style and perfect lines. ...
(Date:11/23/2014)... NY (PRWEB) November 23, 2014 ... allege heart attacks, strokes, deep vein thrombosis and ... in a federal multidistrict litigation (MDL) underway in ... reports. , Court documents updated on November ... Litigation (JPML) show the filing of 259 lawsuits ...
(Date:11/23/2014)... This evaluation provides a basic conclusion ... and manufacturing technological innovation. Then, the evaluation investigates ... in information. In this part, the evaluation provides ... and 2009-2014 market shares for each company. Through ... and Chinese suppliers finish market of Femoral Occurs ...
(Date:11/23/2014)... 2014 AngelWeddingDress.com has recently ... selection of beach wedding dresses. “If you are looking ... AngelWeddingDress.com as soon as possible. Here you can enjoy ... manager says. , Holding a big marriage ceremony is ... a beautiful beach wedding dress is uppermost priority. Ophelia, ...
Breaking Medicine News(10 mins):Health News:Dr. Michael Kettel of San Diego Fertility Center Gives “An Inside Look at Freezing Eggs” on NBC 2Health News:Dr. Michael Kettel of San Diego Fertility Center Gives “An Inside Look at Freezing Eggs” on NBC 3Health News:Beautiful Wedding Dresses Available at Popular B2C Company Tidebuy 2Health News:Testosterone Lawsuits Approach 260 in Illinois Federal Court Litigation, Bernstein Liebhard LLP Reports 2Health News:Testosterone Lawsuits Approach 260 in Illinois Federal Court Litigation, Bernstein Liebhard LLP Reports 3Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 2Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 3Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 4Health News:Beach Wedding Dresses Added to Outstanding Online Dress Company AngelWeddingDress.com 2
... Biologist Lee Ligon has found a previously unknown connection ... tissue. The results provide new information on the earliest ... published March 7, 2012, in the journal PLoS ... Cell-Cell Adhesion between Breast Cancer Epithelial Cells and Fibroblasts." ...
... Loyola University Chicago Stritch School of Medicine study has revealed ... enables cancer cells to establish tumors in distant parts of ... new drugs to prevent breast cancer and other cancers from ... PhD and colleagues is published in the March 16 ...
... new study by University of Kentucky researchers provides insight ... commonly known as triple-negative breast cancer. This cancer is ... occurs at women at a younger age. Tumor ... migration and reduces adhesion between cells to spread to ...
... philosophers will come together at a special conference next month ... Among the questions for discussion will be: Is the ... citizens to make them fit for work? Or is it ... ,Civil Association, is the spring conference of the Think About ...
... is available in German . Every cell ... separates the distinct internal environment of the cell from the ... as plasma membrane, disturbs the cellular functions and may lead ... tears many little holes into the plasma membranes of the ...
... large international study indicates that anti-inflammatory drugs may become ... disease (CHD), the leading global cause of death. In ... heart disease, the researchers used the Cardiochip, a gene ... researcher in the Center for Applied Genomics at The ...
Cached Medicine News:Health News:Biologists uncover surprising connection between breast cancer cells and surrounding tissue 2Health News:How cancer cells start new tumor sites 2Health News:New study shows promise for developing new treatments for breast cancer 2Health News:Conference explores ethical dimension of NHS 2Health News:How muscle cells seal their membranes 2Health News:Gene chip invented by CHOP scientist pinpoints new target to prevent heart disease 2
(Date:11/22/2014)... noviembre de 2014  BioClinica®, Inc., un proveedor ... tecnologías eClinical, ha indicado un aumento de la ... el seguimiento basado en el riesgo en los ... del seguimiento basado en el riesgo más allá ... seguimiento o cambio de los métodos de seguimiento. ...
(Date:11/22/2014)... , Nov. 21, 2014 MEDITE Group acquired by ... months and the 3 rd quarter sales ended September ... was $448,000 for the nine months ended September 2014 and ... though our 3 rd quarter is usually a seasonable ... from July into September for many countries worldwide, we are ...
(Date:11/22/2014)... 21, 2014 Many power shifts are ... influence of patients in the biopharmaceutical market is ... more than ever, understanding how to effectively acquire, ... is essential. According to recent ... companies spent about two-thirds of their patient-focused dollars ...
Breaking Medicine Technology:El 'seguimiento inteligente' consigue un excelente momento 2El 'seguimiento inteligente' consigue un excelente momento 3CytoCore Inc. / MEDITE Cancer Diagnostics, Inc. Reports Record YTD and 3rd Quarter Sales 2CytoCore Inc. / MEDITE Cancer Diagnostics, Inc. Reports Record YTD and 3rd Quarter Sales 3New Report Details Importance of Adopting a "Patient Journey" Framework in Marketing 2
The Elisa test is used for the detection and semi-quantitative determination of IgG, antibodies to myeloperoxidase in human sera as an aid to the diagnosis is of microscopic polyangiitis....
... this Enzyme ImmunoAssay (EIA) is as follows: ... on a 96 well microtiter plate. After ... the trapped molecule is covalently linked to ... After washing and denaturing treatment, Angiotensin II ...
... a solid phase two-site enzyme immunoassay. ... sandwich technique in which two monoclonal ... determinants on the insulin molecule. During ... with peroxidase-conjugated anti-insulin antibodies and anti-insulin ...
... SAS RSV antigen test is ... for the presumptive qualitative detection ... from nasopharyngeal specimens in neonatal ... 15 minute test has a ...
Medicine Products: