BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

GE Healthcare Announces FDA Approval To Supply Technetium 99m Generators


5/30/2014 6:55:36 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

GE Healthcare Announces FDA Approval to Supply Technetium 99m Generators

PRINCETON, N.J.--(BUSINESS WIRE)-- Effective from June 1st 2014 and following approval by the US Food and Drug Administration (FDA), GE Healthcare today announced the intent to supply generators for the production of sodium pertechnetate; technetium (Tc99m) injection to its radiopharmacies in the US.

Globally more than 70 percent of all diagnostic SPECT (single photon emission computed tomography) procedures using gamma cameras rely on the use of Tc99m as the radioactive component. It is commonly used as an imaging agent and in preparation of FDA-approved diagnostic radiopharmaceutical kits to help diagnose many different types of diseases including those in cardiology, oncology, and neurology.

GE Healthcare is responsible for more than 30 percent of the world’s supply of radioactive tracers and has 31 radiopharmacies in the US.

“Radioactive tracers are difficult to manufacture because of their short half-life. By supplying our generators, GE Healthcare has better control over its supply chain. It could also help to increase the availability of Tc99m for our customers in the longer term,“ said Jan Makela, GM, Core Imaging. “Currently we supply Tc99m generators (branded Drytec™ outside the US) to many countries around the world and the inclusion of the US is a big step to increasing our leadership in this market. It represents a significant growth opportunity for our SPECT business.”

Technetium-99m, when used as a radioactive tracer, can be detected in the body by medical equipment such as gamma cameras. The short physical half-life, or time it remains radioactive, of the isotope and its biological half-life of 1 day (in terms of human activity and metabolism) allows for scanning procedures which collect data rapidly but keep total patient radiation exposure low.

Important Risk and Safety Information for Sodium Pertechnetate Tc99m Injection

Long term cumulative radiation exposure is associated with increased risk of cancer. Radiation risks associated with the use of sodium pertechnetate Tc99m injection are greater in children than in adults. In general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to insure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Allergic reactions including anaphylaxis have been reported infrequently following the administration of sodium pertechnetate Tc99m. Technetium Tc99m is excreted in human milk during lactation so formula feedings should be substituted for breast feedings.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

For our latest news, please visit http://newsroom.gehealthcare.com

Contact:
Media Contact:
GE Healthcare
Scott Lerman
609-514-6346 (office)
609-937-9253 (mobile)
scott.lerman@ge.com

Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com


   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->