GE Healthcare Announces FDA Approval to Supply Technetium 99m Generators
May 30, 2014
Princeton, NJ -- May 30, 2014 -- 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 itsbiological 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 (NYSE: 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.
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 (NYSE: 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.
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