Varian TrueBeam Radiotherapy Systems Get FDA Clearance

March 20, 2026 — Siemens Healthineers recently announced its Varian TrueBeam radiotherapy systems, which include TrueBeam, TrueBeam STx, VitalBeam and Edge, have received FDA 510(k) clearance for the use of low-dose radiation therapy (LDRT) in adults with medically refractory osteoarthritis (OA). This clearance expands Varian’s radiotherapy systems beyond cancer care into chronic musculoskeletal conditions, bringing precision radiotherapy to millions of people living with persistent pain and limited mobility.

Osteoarthritis affects more than 33 million adults in the U.S.,¹ and around 600 million worldwide.² The number of cases is rapidly increasing, due to aging, obesity and injury.³ While many patients manage symptoms with medications or other treatment options, a substantial number continue to experience pain and reduced quality of life. For these individuals, the newly cleared indication offers a non-invasive, outpatient treatment option based on a growing body of evidence demonstrating that LDRT can target inflammation at the source, reduce pain, improve joint function and delay the need for surgical intervention.^4-8

“This FDA clearance is a meaningful step toward integrating low-dose radiotherapy into routine care pathways for adults with medically refractory osteoarthritis,” said Gopal K. Bajaj MD, emeritus chairman and medical director of the Advanced Radiation Oncology and Proton Therapy Department at Inova Schar Cancer and president of Radiation Oncology Associates. “It gives patients and advocates greater confidence in a clearly defined, regulated treatment option. For clinicians, it supports more consistent referrals and reimbursement discussions while encouraging responsible adoption and real-world outcomes tracking.”

The latest FDA clearance builds on the TrueBeam platform’s advanced capabilities in imaging and precision beam delivery, making innovation accessible to more patients. The system combines high-resolution imaging with accurate dose control, enabling clinicians to provide personalized care with exceptional precision while maintaining the same streamlined workflows they trust for cancer care.

“This clearance is a powerful example of how we’re expanding the reach of precision radiotherapy to meet broader healthcare needs,” said Arthur Kaindl, head of Varian. “At Siemens Healthineers, we’re uniquely positioned to lead this transformation by bringing imaging and therapy together to improve lives not just in cancer care, but now in chronic conditions like osteoarthritis.”

This clearance also builds on Varian’s list of regulatory approvals in non-oncological indications, including radiosurgery treatment for medically refractory essential tremor in adults, a functional disorder of the brain that causes severe impairment in patients’ quality of life. Learn more about the Varian TrueBeam platform and watch a video featuring a patient with essential tremor and her treatment journey.

Reference

1. Foster AL, Boring MA, Lites TD, Croft JE, Odom EL, Fallon EA. Distribution of Arthritis Subtypes Among Adults With Arthritis in the United States, 2017–March 2020. Prev Chronic Dis 2025;22:240393. DOI: http://dx.doi.org/10.5888/pcd22.240393

2. GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. PMID: 37675071; PMCID: PMC10477960

3. World Health Organization. Osteoarthritis. World Health Organization. Published July 14, 2023. Accessed February 2, 2026. www.who.int/news-room/fact-sheets/detail/osteoarthritis/

4. Dove APH, Cmelak A, Darrow K, McComas KN, Chowdhary M, Beckta J, Kirschner AN. The Use of Low-Dose Radiation Therapy in Osteoarthritis: A Review. Int J Radiat Oncol Biol Phys. 2022 Oct 1;114(2):203-220

5. DEGRO Guidelines In Radiotherapy (2022): Radiotherapy for benign diseases. Ver 3.0 19.11.2022: Osteoarthritis:P33-49.

6. Fazilat-Panah D, Javadinia SA, Shabestani Monfared A, Attarian F, Babaei M, Yousefghahari B, Najafzadeh Sadati S, Ahmadi N, Fallah Tafti H. Effects of low dose rate radiotherapy on pain relief, performance score, and quality of life in patients with knee osteoarthritis; a double-blind sham-controlled randomized clinical trial. Int J Radiat Biol. 2025 Mar 5:1-8.

7. Yu JB, Grew DJ, Spraker MB, Beckta JM, Shah C, Brower JV. Radiation Therapy for the Treatment of Osteoarthritis. Pract Radiat Oncol. 2025 Jan-Feb;15(1):19-24.

8. Koneru BN, Sick J, Shaikh HA, Spengler H, Small W Jr, Shaffer R. Low-Dose Radiation Therapy for Osteoarthritis: A Retrospective Single-Institution Analysis of 69 Patients and 168 Joints. Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):352-360.