ZDi Solutions announced that it has received approval from the U.S. Food and Drug Administration for its Z-System patient positioning devices for proton therapy and conventional radiation therapy. The company announced in late September that it has begun marketing both in the U.S. and internationally. The system is comprised of the Z-Box, Z-Square and Z-Tilt.
“FDA approval was the next step in our launch process, and we are now excited to introduce this product to the radiation oncology community with full credentials,” said John Hawkins, CEO of ZDi Solutions.
The devices, developed by Zachary Dutton, Chief Design Officer of ZDi Solutions, recognized and filled the need for proton-specific, patient-receptive positioning treatment aides.
“I am very pleased to have passed the rigorous FDA process. I believe this further proves the safety, design, and quality of the ZDi, Solutions LLC devices,” said Dutton.
The Z-System provides an innovative and revolutionary patient positioning unit to the proton therapy and conventional radiation therapy markets. The unique, add-on line of patient centered products allows for greater efficiency and accuracy in simulation and treatment set-ups, thus allowing for increased quality and decreased liability.
The Z-System is the first of its kind to specifically target the needs and circumstances of proton therapy staffs and patients, while demonstrating to be beneficial for conventional radiation therapy treatments. The initial products of the line aim to allow for best practices in patient positioning of the breast and thoracic areas; follow-up devices will focus on other anatomical regions and will operate cooperatively within the system.
ZDi Solutions has successfully tested and researched the device at the Provision Center for Proton Therapy in Knoxville, TN.
“In addition to collaborative opportunities with U.S. radiation oncology providers, there has been significant international distribution interest from new and existing proton centers in Asia and India,” said Hawkins. “These are exciting markets that we are hopeful to explore.”