Jubilant DraxImage has received approval from the US Food and Drug Administration (FDA) for its Ruby-Fill technology for positron emission tomography (PET) myocardial perfusion imaging (MPI).
The new Ruby-Fill includes Rubidium-82 (Rb-82) generator and precedent setting elution system.
It will produce a personalized patient dose of Rubidium Rb 82 chloride that is used to assess regional myocardial perfusion in adult patients with suspected or existing coronary artery disease (CAD).
Ruby-Fill generator includes an accelerator produced Strontium-82, which disintegrates to Rubidium-82.
The generator will be eluted with saline to produce a sterile and non-pyrogenic solution of Rb-82 Chloride.
The elution system will be used to deliver Rb-82 Chloride into the patient to carry out MPI with PET.
According to the company, the Rubidium elution system has been exclusively designed to be used with the Ruby-Fill generator and deliver accurate doses of Rb-82 Chloride to patients
Jubilant DraxImage parent firm Jubilant Pharma CEO GP Singh said: “We are proud to bring to the US market a groundbreaking, state-of-the-art technology for myocardial perfusion imaging.
“Ruby-Fill expands DraxImage’s nuclear medicine portfolio and is a part of our commitment to provide healthcare providers and their patients with innovative health care solutions for those with suspected or existing coronary artery disease.”
Jubilant Pharma and Jubilant DraxImage medical and regulatory affairs senior vice president and chief medical officer Dr Norman LaFrance said: “Our knowledge of the role and value of PET nuclear cardiology, specifically Rb- 82 Chloride PET in known or suspected coronary artery disease, advanced significantly as we progressed through the comprehensive and rigorous FDA review process.”