FDA Assigns Breakthrough Status to Indian Cancer Device

The F.D.A’s  Center for Devices and Radiological Health designated an invention developed by Dr. Rajah Vijay Kumar as a “breakthrough device” in the treatment of liver, pancreatic, and breast cancers.  Gaithersburg, MD-based Shreis Scalene Sciences LLC presented the device to the USFDA which released a communique that said, “We are pleased to inform you that your device and proposed indication for use met the criteria and have been granted designation as a breakthrough device.”

Biomedical researcher Dr. Kumar developed Cytotron at the Center for Advanced Research in Bhopal,India  after nearly 30 years of research into cellular pathways and interactions with specifically modulated fast radio bursts (FRB). Cytotron uses FRBs to communicate with the cellular command and control, to up- or down-regulate a specific protein or gene, Kumar said. The device is intended to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival.