Navigation Links
FDA Permits Marketing of First Test to Help Diagnose Dengue Fever
Date:4/8/2011

will now aid health care professionals in their effort to more effectively diagnose dengue."

The FDA reviewed data for the test via the "de novo" pathway, an alternative path to market for devices that are low to moderate risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a "510(k)" premarket notification.

People who believe they have dengue should immediately contact a health care professional. There are no FDA-licensed vaccines to prevent dengue and no medicines specifically approved to treat the infection.

The test should not be used in people who do not show signs or symptoms of dengue. Diagnostic testing for dengue is complicated by the fact that an IgM antibody response to the dengue virus infection is not detectable until 3-5 days after the onset of fever, which can produce a negative test result even though a person has dengue. During this "IgM negative window" the dengue virus is present in the bloodstream.

There are currently no FDA-cleared or approved tests for direct detection of dengue virus.

This new test shows cross-reaction with other closely related viruses such as those that cause West Nile disease. However, in most patient testing situations found in the United States, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Evaluation of Automatic Class III Designation (De Novo) Decision Summaries

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm232269.htm

CDC: Dengue

http://www.cdc.gov/dengue/

The FDA, an
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Vystar® Corporation Appoints Joanne Kearney as Vice President of Marketing
2. SinoFresh HealthCare Signs Three Sale Marketing Agreements
3. Cynosure Receives International Marketing Clearances for New Cellulite, Laser Lipolysis Products
4. Streamline Health Appoints Rick Leach as Senior Vice President and Chief Marketing Officer
5. ViewRay Receives FDA 510(k) Marketing Clearance for Treatment Planning and Delivery Software
6. Caliper and Covaris Establish Co-Marketing Agreement to Simplify Next Generation Sequencing
7. Behavioral Marketing Goes Mobile
8. Thought Leader Select Announces Media Partnership with Marketing4Health
9. Simcere Pharmaceutical Group Appoints Industry Veteran Mr. Hong Zhao as Executive Vice President of Sales and Marketing
10. Peter Dannenfelser Joins Targetbase as Vice President of Strategy, Bringing 15 Years of Pharmaceutical Marketing Experience
11. Thats Nice LLC Launches Nice Insight Marketing Intelligence for CRAMs With Its Pharma & Biotech Outsourcing Survey
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... YORK , August 21, 2014 ... Israeli subsidiary, BreedIT Ltd., the exclusive worldwide license ... software for plant breeders and researchers, today is ... a joint venture with Seach Ltd, a leading ... formed to research and develop new breeds of ...
(Date:8/21/2014)... 2014  AliveCor, Inc. announced today that ... has granted the company clearance for its ... most common form of cardiac arrhythmia. AliveCor,s ... patients are experiencing AFib through real-time electrocardiogram ... based AliveCor® Heart Monitor, so physicians can ...
(Date:8/21/2014)... , Aug. 21, 2014   Royal ... PHIA) today announced it has received 510(k) clearance ... market its precision planning application for Transcatheter Aortic-Valve ... TAVI application provides interventionalists with pre-procedural, high-precision positioning ... Philips TAVI planning application is available as part ...
Breaking Medicine Technology:BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 2BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 3BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 4AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device 2Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application 2Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application 3
(Date:8/21/2014)... (HealthDay News) -- Among seniors, dimming vision may be ... involved more than 2,500 people, aged 65 to 84, who ... two, six and eight years later. Vision loss over ... of death during the study period, the researchers reported. ... by Sharon Christ of Purdue University in West Lafayette, Ind., ...
(Date:8/21/2014)... New York, New York (PRWEB) August 21, 2014 ... ) filed against C.R. Bard, Inc. continue to ... in U.S. District Court, Southern District of West ... Pretrial Order issued on August 14th, the Court ... biomaterials evidence that requires special handling, division, storage ...
(Date:8/21/2014)... is to focus on her body in terms of ... her as a complete human being with thoughts and ... in the media, how does it affect individual romantic ... Quarterly , a SAGE journal, finds that more objectification ... incidents of sexual pressure and coercion., Researchers Laura R. ...
(Date:8/21/2014)... The results of a large, retrospectives ... of the American Medical Association (JAMA) show that 3D ... unnecessary recalls. Memorial Healthcare System was one of 13 ... study confirms what we already know – 3D mammography ... to find and, at the same time, saves women ...
(Date:8/21/2014)... 2014 The report "Industrial Flue ... Control System (FGD, DeNOx, Particulate Control, Mercury Control) ... Chemical & Others) - Global Trends & Forecasts ... flue gas treatment systems & services market with ... in terms of value. The industrial flue gas ...
Breaking Medicine News(10 mins):Health News:Failing Vision Tied to Shorter Lifespans for Seniors 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 3Health News:Objectification in romantic relationships related to sexual pressure and coercion 2Health News:Dr. Mary Hayes: Study Shows 3D Mammography Finds More Invasive Cancers While Reducing Unnecessary Recalls 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 3Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 4
... Annual buy-back program expects to collect 16 tons of ... American consumes more,than 24 pounds of candy per year, ... Halloween*. For most people, this year,s candy noshing will,simply ... 5 million,North Americans in orthodontic treatment, Halloween treats can ...
... Pain Following Ostomy,Surgery, SKILLMAN, N.J., Oct. 28 ... care products, announced today the launch,of SUR-FIT Natura(R) ... offers clinicians and ostomy patients a simple and,gentle ... and weeks following,surgery., The SUR-FIT Natura(R) Low-Pressure ...
... Par,Pharmaceutical Companies, Inc. (NYSE: PRX ) announced today that ... November 7, 2008 at 9:00,am EST to review results for ... results after the market closes on Thursday,November 6, 2008. The ... http://www.parpharm.com ., Access to the live webcast can be ...
... a Necessity, WASHINGTON, Oct. 28 Recent ... regular vacations contribute to,better health, relationships and job ... don,t vacation regularly are 32 percent more likely,to ... more likely.(1) In an effort,to encourage Americans to ...
... announced that despite an overall increase in news reporting ... media coverage has become significantly more negative. "How the ... breast, colorectal and prostate cancer coverage, was an independent ... analyses were issued in 2000 and 2004. The report ...
... 28 For World Psoriasis,Day, Oct. 29, the ... Web site, http://www.psoriasis.org, and sign up ... disease of the,immune system that appears on the ... Day, awareness activities will,occur all over the world ...
Cached Medicine News:Health News:Orthodontists Offer Sweet Incentives for Tricky Halloween Treats 2Health News:Orthodontists Offer Sweet Incentives for Tricky Halloween Treats 3Health News:ConvaTec Launches SUR-FIT Natura(R) Low-Pressure Adaptor 2Health News:ConvaTec Launches SUR-FIT Natura(R) Low-Pressure Adaptor 3Health News:Video: Regular Vacations: Prescription for a Healthy Lifestyle 2Health News:Video: Regular Vacations: Prescription for a Healthy Lifestyle 3Health News:Media coverage of lung cancer is increasing, and increasingly negative, new report shows 2Health News:National Psoriasis Foundation Seeks 10,000 Americans to Support Psoriasis Research for World Psoriasis Day 2Health News:National Psoriasis Foundation Seeks 10,000 Americans to Support Psoriasis Research for World Psoriasis Day 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: