Jubilant receives US FDA approval for Ruby-Fill in heart test

Ruby-Fill’s computer-controlled interface underwent rigorous software verification and FDA review. It allows for improved user experience and efficiency with flexible and unique patient dosing options which can be defined for specific clinical question. The system also provides enhanced patient and healthcare professional safety features along with automated QC and volume tracking as compared to currently available options in the PET myocardial perfusion imaging (MPI) segment. 

Also, Rubidium-82 MPI has been clinically demonstrated in published peer reviewed journals to have superior sensitivity, specificity and accuracy versus current SPECT MPI studies. Importantly, Ruby-Fill has significantly lower patient radiation exposure as compared to current Single Photon Emission Computed Tomography (SPECT) MPI procedures which have 5-20 times the patient radiation exposure as compared to Ruby-Fill.

“We are very excited to receive the much-awaited USFDA approval for Ruby-Fill, a cutting-edge technology for PET MPI for diagnosis of coronary artery disease. Ruby-Fill expands DraxImage’s nuclear medicine portfolio and is a testimony to our innovation and capability to launch one of our differentiated and niche pipeline products in our Specialty business. This approval is highly anticipated by the medical community and is expected to give further boost to the revenues and profitability of the company along with the robust existing product base,” said Shyam Bhartia, chairman and Hari Bhartia, co-chairman and managing director, Jubilant Life Sciences Limited, in a press statement.