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May 25, 2012 11:54 pm US/Eastern
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POSITRON CP : [Positron Corporation] Positron Comments on Recent FDA CardioGen Recall

07/28/2011 | 03:40pm

The Food and Drug Administration has recently suggested a voluntary recall of the Bracco Diagnostics, CardioGen generator product.  Information regarding this voluntary recall can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm265278.htm.  

Based on all the information available we are confident that this recall will be resolved in the near term.

As an immediate and interim solution, Positron is assisting its current and potential customer base in transitioning to 13N-Ammonia where availably permits.  13N-Ammonia availability is based on proximity to a cyclotron.

Positron continues its commitment to the growth and strength of Cardiac PET imaging as evidenced by the internal development and external sourcing of Rb-82 generators and the future availability of Sr-82 isotope that is planned to be produced from a Positron high energy cyclotron currently under development.

The future of nuclear cardiology is PET.  Positron maintains its approach to offer radiopharmaceutical consumables to customers in both the cardiac PET and SPECT markets; critical components for our expansion, strength and long-term strategy is to secure a supply of isotopes and offer radiopharmaceuticals as well as our PET scanner thereby offering the security that our full cardiac solution be available to our customer base for the foreseeable future.

 
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