RTsafe (Athina, Greece) recently announced that it has won FDA 510(k) clearance for its Personalized PseudoPatient PV device.
The Personalized PseudoPatient PV provides a precise model of a patient’s CT scan. The system 3D prints bone structure and an external contour using bone equivalent material. It is designed to be used for the quality assurance of patient-specific brain treatments that are done before and inter-fractionally delivered by beam radiotherapy. It is also designed for the quality assurance of radiation delivery systems.
”RTsafe’s Personalized PseudoPatient is a major step towards increasing the safety and efficiency of radiation therapy by enhancing confidence among both radiation oncologists and cancer patients”, said Evangelos Pappas, CEO and founder of RTsafe, in a press release. “After the 510(k) FDA clearance, our technology and personalized quality assurance solutions are now available to all US brain cancer patients. Given the critical importance of accuracy in brain radiotherapy, we believe that health professionals and patients alike will welcome the opportunity to simulate and verify treatment in a totally safe environment before irradiating live tissue.”
Dosimetry phantoms in the system are built from real patient anatomical data and combine expertise in medical physics with highly accurate 3D printing technology. It features accurate dose verification and absolute measurement and is compatible with any treatment planning system (TPS) while offering patient quality assurance and machine assurance capabilities.
The system allows radiotherapy professional to test all radiotherapy procedures on anatomically perfect facsimile of a patient before they perform any treatment. The company also suggests that the system can be used as an additional measure to conventional commissioning quality assurance of radiation delivery equipment on real clinical cases.
Jalex Medical provided regulatory affairs support during the FDA clearance process as well.
“It’s exciting to see the continued advancements that are being made in the medical industry with 3D printing, and the PseudoPatient device is yet another example of brilliant forward thinking that can improve outcomes for many cancer patients,” Jennifer Palinchik, president of Jalex Medical, said.
