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 success of a plan for regaining compliance with certain continued listing standards of the American Stock Exchange, successful development or marketing of the Company's products, the competitiveness of the Company's products if successfully commercialized, the lack of operating profit and availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, product liability, reliance on third-party manufacturers, the ability of the Company to take advantage of business opportunities, uncertainties related to the regulatory process, and general changes in economic conditions.

In addition, while the Company routinely obtains patents for its products and technology, the protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates.

Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. PreMD is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

(x) Trademark


'/>"/>
SOURCE PreMD Inc.
Copyright©2007 PR Newswire.
All rights reserved

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:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best Buy Eyeglasses, ... the United States and Canada wear eyeglasses. Once considered to be a purely functional ... a fashion statement. Even celebrities use glasses as a way of creating an iconic ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... , June 24, 2016 ... has announced the addition of the " Global ... This report ... provides an updated review, including its applications in various ... total market, which includes three main industries: pharmaceutical and ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: ... and sells medical devices and wearable sleep respiratory products ... cooperation agreement with Hongyuan Supply Chain Management Co., Ltd. ... 20, 2016, to develop Dehaier,s new Internet medical technology ... will leverage Hongyuan Supply Chain,s sales platform to reach ...
Breaking Medicine Technology: