Jubilant DraxImage has secured CE mark approval for its Ruby rubidium elution system (RbES) and Ruby consumable accessories to market in the European Economic Area (EEA).
The approval allows to use RbES and Ruby consumable accessories with the company’s Ruby-Fill (Rubidium Rb82 generator).
Jubilant Pharma medical and senior vice-president and chief medical officer Dr Norman LaFrance said: “Jubilant DraxImage is extremely excited about the CE Mark certificate, which will provide expanded access of this next-generation PET product into the EEA.
“With its advanced weight-based dosing accuracy and infusion options, RUBY-FILL will enhance the way patients with known or suspected coronary artery disease are both diagnosed and managed.”
Ruby-Fill generator and the Ruby rubidium elution system are said to offer the latest technology in positron emission tomography (PET) myocardial imaging.
Ruby-Fill is a closed system used for the production of personalized patient doses of rubidium (Rb82) chloride injection for intravenous use.
The Rb82 chloride injection is a radioactive diagnostic agent developed for PET imaging of the myocardium under rest or pharmacologic stress conditions to assess regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
Jubilant Pharma CEO Pramod Yadav said: “This approval is another landmark event for Jubilant DraxImage, supporting its ongoing commitment to the global expansion and utility of nuclear medicine and PET imaging.
“Our goal is to grow SPECT and PET imaging globally by providing products that enable physicians to deliver high-quality diagnostic studies as part of our mission of Improving Lives Through Nuclear Medicine.
Jubilant DraxImage, a subsidiary of Jubilant Life Sciences, is involved in the development, manufactures and commercialization of radiopharmaceuticals for the diagnosis and treatment of disease.
The company, which is dedicated to nuclear medicine, is a major provider of I-131 products for diagnosis and treatment of thyroid disorder and cancer, MAA for lung perfusion imaging, DTPA for renal and brain imaging and MDP for bone imaging.
Jubilant also sells other products such as sestamibi for myocardial perfusion imaging and gluceptate for brain and renal imaging.