Navigation Links
PreMD Announces FDA Decision on POC Skin Cholesterol Test
Date:1/15/2008

Company to Immediately Address FDA Ruling

TORONTO, Jan. 15 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) announced today that it has received a non-substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. The company expects to evaluate its options as part of the plans to address this issue.

"We are very disappointed with this decision by the FDA regarding our 510(k) submission. We believe we have provided adequate information to support clearance and continue to believe that our product merits clearance by the FDA," said Brent Norton, president and chief executive officer of PreMD. "The company is pursuing the next steps in addressing the decision and we will work through the process as expeditiously as possible. We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease. Furthermore, our recent clinical achievements such as our presentation at the American Heart Association and scheduled publication in the American Journal of Cardiology for April show that we are supported in our belief of the strength of our product. The company has adequate cash to support operations through the near term. However, we will continue to evaluate and decrease spending throughout the organization to ensure our ability to execute the necessary tasks."

The FDA's primary grounds for rejecting the claim relate to the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k) application to the FDA in June 2007 based on a study design that was previously accepted as appropriate by the FDA. Subsequently, the FDA requested additional information regarding statistical clarification on the data submitted. The company promp
'/>"/>

SOURCE PreMD Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. PreMD Provides Update on 510(k) Application for PREVU(x) POC
2. PreMD Inc. Provides Corporate Update
3. PreMD Announces Valuable Data on PREVU(x) LT Life Insurance Product
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... Dawn Echols’ professional background spans success ... This experience has honed her people skills and ... professional counseling ( http://dawningphoenix.com ) work includes private ... in domestic violence. , As owner and ... counseling individuals and groups for a variety of ...
(Date:7/28/2014)... Elementary school students seem to be satisfied with the healthier ... study of school officials. , , New meal standards -- ... effect in the fall of 2012. At the time, there ... away most of their food. But the new study of ... , , "The updated meals standards are resulting in healthier ...
(Date:7/28/2014)... Ticket Down is reliable source for cheap ... at the Cotton Bowl. The 2014 Guinness International Champions ... is an eight team tourney. The tournament participants are ... La Liga, Serie A, English Premier League, and Superleague Greece. ... the pitch include: Manchester United, Manchester City, Olympiacos, Inter ...
(Date:7/28/2014)... TN (PRWEB) July 28, 2014 ... Operation Military June . Renowned LASIK and ... June" to provide significant funds and public awareness ... and retired military personnel and their families. “This ... will proudly give nearly $5,000 to a variety ...
(Date:7/28/2014)... Massachusetts (PRWEB) July 28, 2014 ... Summit Provider Exchange technology solution in ... integration efforts and support collaboration with their New ... bed acute-care medical center located in New Jersey, ... seasonal visitors with a variety of inpatient and ...
Breaking Medicine News(10 mins):Health News:Dawn M. Echols, M.S., LPC of Dawning Phoenix Speaks at Newly Formed Task Force 2Health News:Healthy School Lunches Get Thumbs Up From Students 2Health News:Real Madrid vs. AS Roma Tickets Cotton Bowl Dallas, TX: Ticket Down Cuts Ticket Prices for AS Roma vs. Real Madrid International Champions Cup Tickets 2Health News:Real Madrid vs. AS Roma Tickets Cotton Bowl Dallas, TX: Ticket Down Cuts Ticket Prices for AS Roma vs. Real Madrid International Champions Cup Tickets 3Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 2Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 3Health News:Cape Regional Medical Center Chooses Summit Provider Exchange to Connect With NJSHINE and Physician Offices 2Health News:Cape Regional Medical Center Chooses Summit Provider Exchange to Connect With NJSHINE and Physician Offices 3
... , ST. PETERSBURG, Fla., Sep. 16 eMed-ID, ... the launch of eMed-Trac, a live instant tracking device designed ... children who need to be closely supervised by parents for ... The eMed-Trac device operates through global positioning satellites ...
... , , GAITHERSBURG, Md., Sept. 16 On ... a notice from The NASDAQ Stock Market stating that the minimum ... share for 30 consecutive business days and that the Company was ... has no effect at this time on the listing of the ...
... Beef, dairy most likely to lead to overindulgence, lab study ... stop eating fatty food? Blame your brain, researchers say. , ... fat travel to the brain, which then tell the body ... "Normally, our body is primed to say when we,ve had ...
... ATLANTA and LONDON, Sept. 16 ... security services, is streamlining the Payment Card Industry (PCI) ... (ITO) Self-Assessment Questionnaire processes with Predefined Assessment Programs. ... the PCI and FFIEC guidelines. An organization,s ...
... , , INDIANAPOLIS, Sept. 16 ... leading provider of innovative consumer health care services under the Arcadia ... CFO Matthew Middendorf will present at the Wall Street Analyst Forum,s ... 29. , , Arcadia will present ...
... WASHINGTON, Sept. 16 While research shows many American children ... - is reversing the trend by motivating them to be more ... To view the Multimedia News Release, go to: ... was launched in 2005 by Boys & Girls Clubs of America ...
Cached Medicine News:Health News:World's First Emergency Medical Information Franchise Launches GPS Tracking Device 2Health News:World's First Emergency Medical Information Franchise Launches GPS Tracking Device 3Health News:World's First Emergency Medical Information Franchise Launches GPS Tracking Device 4Health News:GenVec Receives NASDAQ Notice of Minimum Bid Price Non-Compliance 2Health News:GenVec Receives NASDAQ Notice of Minimum Bid Price Non-Compliance 3Health News:SecureWorks, Inc. Streamlines the PCI AOC and FFIEC ITO Self-Assessment Questionnaire Processes with Predefined Assessment Programs and Affiliate Compliance Summary Reports 2Health News:SecureWorks, Inc. Streamlines the PCI AOC and FFIEC ITO Self-Assessment Questionnaire Processes with Predefined Assessment Programs and Affiliate Compliance Summary Reports 3Health News:Arcadia Resources to Present at Wall Street Analyst Forum Investor Conference in New York 2Health News:Video: Teen Girls Less Active, but Triple Play Program Bucks Trend 2Health News:Video: Teen Girls Less Active, but Triple Play Program Bucks Trend 3Health News:Video: Teen Girls Less Active, but Triple Play Program Bucks Trend 4
(Date:7/28/2014)... 28 luglio 2014 ResMed (NYSE: ... per la cura dei disturbi respiratori del sonno (SDB) ... un,ingiunzione permanente in Germania contro il produttore Taiwanese di ... vendita di apparecchiature da indossare in testa, che violano ... maschere 220. La sentenza della Corte Regionale Distrettuale di ...
(Date:7/28/2014)... , SINGAPORE, and TOKYO , July 28, ... it has appointed Roger Crystal , MD as ... served in the Global Business Development Product Acquisition & ... "Roger,s experience in developing business strategy and partnerships in ... we continue to partner with biotechnology and pharmaceutical companies ...
(Date:7/28/2014)...  ANI Pharmaceuticals, Inc. (NASDAQ: ANIP ) ... second quarter and year-to-date 2014 financial results on Monday, ... financial markets. The earnings press release will be accessible ... www.anipharmaceuticals.com . Arthur S. Przybyl ... C. Arnold , Vice President and Chief Financial Officer, ...
Breaking Medicine Technology:ResMed riceve un'ingiunzione permanente contro APEX in Germania, continua a far valere i propri diritti per i brevetti in Europa 2ImaginAb Appoints Roger Crystal, MD as Vice President of Business Development 2ANI Pharmaceuticals Schedules Conference Call for Second Quarter 2014 Financial Results 2
Curved shafts with 70 degree angled 3 mm tips. Flat, cross action handle with dull finish. Most popular size or model....
Round handle forceps with delicate angled 9 mm jaws. A small groove on the interior portion of the platform is aligned with the handle and provides additional control of trailing haptic during insert...
Two rows of teeth on jaws provide a firm purchase on the nucleus fragment for removal. Flat handle with dull finish....
O'Gawa-Castroviejo tying forceps, straight shafts, 6 mm tying platforms, wide handle....
Medicine Products: