Radiation oncology company Accuray is seeking approval from the US Food and Drug Administration (FDA) for its Radixact treatment delivery system, Precision treatment planning system and iDMS data management system.
The company has submitted 510(k) premarket notification with the FDA for the three systems.
The systems have been designed to work together and enhance treatment workflow processes.
Multiple Radixact systems will use a single and centralized database for treatment planning and patient data management.
The ring gantry-based delivery system is said to have similar delivery capabilities of devices such as TomoHelical and TomoDirect.
According to the company, the integrated treatment planning system is intended to reduce workflow complexities and save time in the treatment planning process.
Accuray president and CEO Joshua Levine said: "The Radixact system is the next generation TomoTherapy platform and is being designed to leverage its unique architecture, providing a mainstream option for more clinicians.
"The new platform, comprised of the treatment delivery, treatment planning and data management systems, is expected to expand clinical capabilities while significantly increasing the ease and speed with which clinicians can provide precise radiation treatments."
The three systems are currently not available for sale within the US, as well as subject to international regulatory approval or licensing processes for the availability in various geographical locations.