Provision Healthcare’s research, development and manufacturing subsidiary, ProNova Solutions, has secured FDA 510(k) clearance for its SC360 proton therapy system.
This approval comes four years after starting research and development.
This is claimed to be a compact 360 degree pencil beam scanning proton therapy system that is capable of treating patients at all angles without moving the patient, thereby enabling efficient clinical workflows, improved accuracy of treatment, and patient comfort.
ProNova system is expected to be used for patient treatment at the Provision CARES Proton Therapy Center in Knoxville, Tennessee by 2017.
Provision Healthcare launched ProNova in 2012 to develop a technologically advanced proton therapy treatment system.
ProNova makes use of proprietary, superconducting technology to construct compact proton therapy systems.
The ProNova SC360 is claimed to be the only proton therapy system developed in a clinical setting, benefitting from continuous input from physicians, medical physicists, and therapists during the complete course of design and development.
The system comes with pencil beam scanning and advanced imaging with cone-beam CT, all in a compact design.
ProNova Solutions president Joe Matteo said: “Achieving this milestone is an enormous accomplishment for our company and will allow us to offer the most advanced technology without compromising features for proton therapy treatment through systems that are smaller, lighter and easier to install while increasing capabilities compared to our competitors.”
“The ProNova SC360 will not only improve proton therapy treatment, but due to its lower cost, will make proton therapy more accessible to patients worldwide.”
Provision Healthcare executive chairman Terry Douglass said: “Provision Healthcare provides innovative healthcare solutions that CARES for the patient as we offer the ProNova system in developing proton therapy centers around the world.”
Provision Solutions is the sole distributor of the ProNova system and has multiple agreements for development of proton therapy centres utilising the ProNova Solutions systems in the US, Europe and Asia.