FDA Gives 510(K) Clearance to ClearRT™ Helical kVCT Imaging for the Radixact ® System

January 11, 2021

Recently, Accuray Incorporated announced in a press release that they received 510 (k) clearance by the FDA for their imaging system. They received FDA clearance for the ClearRT™ Helical kVCT Imaging for the Radixact System, which is a next-generation TomoTherapy platform.

Accuray is a medical company that designs and develops radiotherapy systems to treat cancer. They wish to create safer and more effective cancer therapies to improve cancer patients’ long-term outcomes.

The ClearRT is a new imaging system that has been designed with the patient’s needs at the forefront. The ClearRT is capable of producing excellent CT images in a rapid and cost-saving manner. Interestingly, the ClearRT doesn’t use cone beam technology like traditional setups. Instead, it uses helical fan-beam imaging, which can be used at kV or MV wavelengths to get the best quality images of soft tissues and much more. The ClearRT can be easily used with the Radixact system to provide advanced radiotherapy for cancer patients.  

“ClearRT is a novel, helical CT imaging solution that we believe addresses an unmet market need. It integrates with other Accuray-only applications, such as Synchrony® Real-time Motion Synchronization and Adaptive Treatment Delivery Technology, on the Radixact System, making it possible for providers to offer a new level of precision and accuracy in the treatment of the simplest to the most complex pathologies,” said Suzanne Winter, chief commercial officer and senior vice president, R&D at Accuray.

Further adding, “Our continuing innovation on the Radixact System is designed to leverage the power of its 360-degree, helical delivery platform to facilitate advanced, hypofractionated and ultra-hypofractionated treatments that support our customers’ efforts to maintain the highest standard of care for their community.”

Accuray plans to start commercializing the ClearRT Helical kVCT Imaging sometime in spring this year. Visit https://www.accuray.com/ to find out about Accuray’s latest radiotherapies.

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