This section highlights FDA-related milestones and regulatory updates for drugs developed by Accuray (ARAY).
Over the past two years, Accuray has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CyberKnife®, Radixact®, and Tomo®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CyberKnife® - FDA Regulatory Timeline and Events
CyberKnife® is a drug developed by Accuray for the following indication: For Treatment in Men with Localized Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CyberKnife®
- Announced Date:
- May 7, 2025
- Indication:
- For Treatment in Men with Localized Prostate Cancer
Announcement
Accuray Incorporated announced that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® System in the treatment of prostate cancer at multiple stages of the cancer journey.
AI Summary
Accuray Incorporated presented new data at the European Society for Radiotherapy and Oncology (ESTRO) meeting, reinforcing the benefits of its CyberKnife® System for treating prostate cancer. The studies showed that CyberKnife®, using stereotactic body radiation therapy (SBRT), effectively treats prostate cancer at multiple stages. This includes its use for high-risk patients as well as for those experiencing recurrence after prostate removal. The data demonstrated that the CyberKnife® System delivers precise and accurate radiation therapy with low rates of urogenital and gastrointestinal side effects, making it a promising, non-invasive treatment option.
Additional findings from real-world evidence support the system’s efficacy, helping clinicians offer personalized cancer care. These results further establish CyberKnife® as a valuable option for managing prostate cancer across different patient profiles, underlining its potential to improve long-term outcomes and quality of life.
Read Announcement- Drug:
- CyberKnife®
- Announced Date:
- December 18, 2024
- Indication:
- For Treatment in Men with Localized Prostate Cancer
Announcement
- Accuray Incorporated announced today an international retrospective multicenter analysis found that radiosurgery (SRS) and fractionated stereotactic radiotherapy (FSRT), delivered with the CyberKnife® System, can provide an effective and time-saving treatment option for brainstem metastases (BSM).
AI Summary
Accuray Incorporated announced that their international retrospective multicenter analysis shows that the CyberKnife® System is an effective and time-saving option for treating brainstem metastases. The study, completed at nine institutions and published in the International Journal of Cancer, analyzed 136 patients who received either radiosurgery (SRS) in one session or fractionated stereotactic radiotherapy (FSRT) in up to five sessions. The results showed high rates of local control over one, two, and three years, along with a solid safety profile, offering a promising treatment for this delicate brain area where surgery is not usually an option.
This study adds meaningful evidence supporting the role of advanced radiation techniques in managing brainstem metastases. It emphasizes that precise, targeted treatments using the CyberKnife® System can help improve patient outcomes and reduce treatment time, potentially making a significant difference in the care of those with challenging brain conditions.
Read Announcement
Radixact® System - FDA Regulatory Timeline and Events
Radixact® System is a drug developed by Accuray for the following indication: To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Radixact® System
- Announced Date:
- January 13, 2025
- Indication:
- To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology
Announcement
Accuray Incorporated announced that that the company's Radixact SynC™ System and CyberKnife® S7™ System have been approved by the Chinese National Medical Products Administration (NMPA).
AI Summary
Accuray Incorporated announced that its Radixact SynC™ System and CyberKnife® S7™ System have received approval from the Chinese National Medical Products Administration (NMPA). This milestone enables medical teams in China to offer advanced radiation therapy solutions using Accuray’s cutting-edge technology. The Radixact SynC System features a helical design that delivers precise doses of radiation from multiple 360-degree rotations. It is the first in China to include both ClearRT® kVCT imaging and Synchrony® real-time adaptive delivery technology, which helps track and adjust the radiation beam as tumors move during treatment.
The CyberKnife S7 System is the latest generation of robotic radiosurgery, capable of treating tumors with sub-millimetric precision in just 1 to 5 outpatient sessions. These approvals support Accuray’s strategy to expand patient access in China, where the demand for efficient and effective radiotherapy is rapidly increasing.
Read Announcement- Drug:
- Radixact® System
- Announced Date:
- September 10, 2024
- Indication:
- To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology
Announcement
Accuray Incorporated announced that Gifu Prefectural General Medical Center is setting a new standard in cancer care in Japan as the first hospital in the country to treat patients with surface-guided radiation therapy (SGRT) using the company's Radixact® Radiation Delivery System and VitalHold™* package.
AI Summary
Accuray Incorporated announced a significant advancement in cancer care at Japan's Gifu Prefectural General Medical Center. This facility is the first in Japan to use surface-guided radiation therapy (SGRT) with Accuray’s Radixact® Radiation Delivery System and VitalHold™ package. SGRT uses high-resolution cameras that create a 3-dimensional map of the patient’s skin, ensuring accurate alignment during radiation treatment. This precision is critical for techniques like deep inspiration breath hold (DIBH), which helps protect the heart during left breast cancer treatments. By employing these innovative technologies, the hospital is improving patient positioning and monitoring throughout each treatment session. This move is set to enhance treatment accuracy and expand access to high precision radiation therapies, marking a new standard in cancer care in Japan.
Read Announcement- Drug:
- Radixact® System
- Announced Date:
- August 13, 2024
- Indication:
- To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology
Announcement
Accuray Incorporated announced that that the Charles L. and Miki N. Grant Cancer Center for Hope medical team is the first in the U.S. to treat cancer patients using the Accuray Radixact® System with VitalHold™* technology.
AI Summary
Accuray Incorporated announced that the Charles L. and Miki N. Grant Cancer Center for Hope medical team is the first in the United States to use the Accuray Radixact® System with VitalHold™ technology for cancer treatment. This groundbreaking technology improves patient positioning and monitors their alignment during radiotherapy. The VitalHold feature uses integrated surface-guided radiotherapy (SGRT) to create a 3D image of the patient’s surface in real-time. It helps clinicians accurately adjust and maintain the patient’s position, ensuring that radiation is delivered precisely to the tumor while protecting nearby healthy tissue.
With this advancement, the Cancer Center for Hope has taken a significant step in offering faster and more effective treatment options. The use of the Radixact System with VitalHold technology is aimed at providing enhanced patient care by increasing the accuracy and efficiency of radiotherapy treatments, contributing to improved outcomes for cancer patients.
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Tomo® C Radiation Treatment Delivery System - FDA Regulatory Timeline and Events
Tomo® C Radiation Treatment Delivery System is a drug developed by Accuray for the following indication: precision radiotherapy for cancer patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tomo® C Radiation Treatment Delivery System
- Announced Date:
- January 23, 2025
- Indication:
- precision radiotherapy for cancer patients
Announcement
Accuray Incorporated announced that Shandong Cancer Hospital and Institute has achieved a milestone with the completion of treatment for 100 patients using the Tomo® C Radiation Treatment Delivery System, a product built in China through the CNNC-Accuray joint venture.
AI Summary
Accuray Incorporated announced that Shandong Cancer Hospital and Institute has reached a significant milestone by treating 100 patients with the new Tomo® C Radiation Treatment Delivery System. This advanced system, developed in China through the CNNC-Accuray joint venture, is based on the helical TomoTherapy platform and is designed to deliver fast, ultra-precise radiation therapy. The technology enables clinicians to treat around 95 patient sessions per day, increasing treatment capacity and offering the potential for more personalized and effective cancer care. By integrating advanced imaging, delivery, and treatment planning tools, the Tomo® C system enhances clinical capabilities and expands options for addressing a broad range of cancers. This achievement not only marks a major step forward for the hospital but also demonstrates Accuray’s commitment to improving cancer treatment in the underserved Chinese radiation therapy market.
Read Announcement
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