Varian TrueBeam Devices Get FDA Nod for Low-Dose Radiation Therapy for Refractory Osteoarthritis

The Food and Drug Administration (FDA) has expanded 510(k) clearance for the Varian Truebeam radiotherapy systems to provide low-dose radiation therapy (LDRT) for people with refractory osteoarthritis.

Noting that over 33 million adults in the United States have osteoarthritis, Siemens Healthineers, the manufacturer of the Varian TrueBeam radiotherapy platforms, said emerging evidence has demonstrated that LDRT provides targeted treatment of the source of inflammation, facilitating improved joint function and delaying the need for surgery.

Siemens Healthineers noted that the Varian TrueBeam radiotherapy platforms provide enhanced precision through a combination of high-resolution imaging and accurate control with radiation dosing.

Gopal K. Bajaj, M.D, the emeritus chairman and medical director of the Advanced Radiation Oncology and Proton Therapy Department at Inova Schar Cancer Institute in Fairfax, Virginia, called the expanded FDA clearance of the Varian TrueBeam radiotherapy systems a significant development for this patient population.

“This FDA clearance is a meaningful step toward integrating low-dose radiotherapy into routine care pathways for adults with medically refractory osteoarthritis,” said Dr. Bajaj. “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 expanded 510(k) clearance for refractory osteoarthritis covers the TrueBeam, TrueBeamSTx, VitalBeam and Edge radiotherapy systems, according to Siemens Healthineers.