Positron Corporation (POSC)

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Product Approval Status

Canada

RUBY-FILL® is the only 82Sr/82Rb generator approved for use by Health Canada. In Canada, the approval process requires that the generator and the elution system be approved separately. Physicians need both the elution system and generator to administer the radiotracer in order to perform the imaging procedure. The elution system is not yet approved for use in Canada. Therefore despite the fact that RUBY-FILL® Rubidium 82 Generator is approved for use,  the Rb-82 system (generator and elution system) can  only be used under approved research protocols at this time.

United States ($$$$$$SOOOOONNNN!!!!)

The JDI Rb-82 system is currently under active review by the US FDA and is not yet available for commercial use.

Rest of World

We are seeking approval of the JDI Rb-82 System in multiple countries.