Siemens Healthineers gains FDA Clearance for radiotherapy system to treat osteoarthritis

Siemens Healthineers announced Friday that the Food and Drug Administration has granted 510(k) clearance for its Varian TrueBeam radiotherapy systems to treat adults with medically refractory osteoarthritis using low-dose radiation therapy.

The clearance covers the TrueBeam, TrueBeam STx, VitalBeam and Edge systems, marking an expansion of radiotherapy technology beyond cancer treatment into chronic musculoskeletal conditions. The approval allows these systems to deliver low-dose radiation therapy to patients whose osteoarthritis has not responded to other medical treatments.

Osteoarthritis affects more than 33 million adults in the United States and approximately 600 million people worldwide, according to the company. Case numbers are rising due to aging populations, obesity and injury.

While many patients manage symptoms with medications or other interventions, a substantial number continue to experience pain and reduced quality of life, the company said.

The newly cleared indication offers a noninvasive, outpatient treatment option. A growing body of evidence suggests that low-dose radiation therapy can target inflammation, reduce pain, improve joint function and delay surgical intervention.

"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, 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."

The TrueBeam platform combines high-resolution imaging with dose control, enabling personalized treatment while maintaining workflows used in cancer care, the company said.

The clearance builds on Varian's previous regulatory approvals for noncancer indications, including radiosurgery treatment for medically refractory essential tremor in adults.

Broader advances in radiation therapy for noncancer conditions

Radiation therapy has historically been synonymous with cancer treatment, but recent years have seen growing clinical interest in applying low-dose radiation techniques to chronic inflammatory and functional disorders. This shift reflects advances in precision targeting, imaging guidance and dose optimization that make it possible to deliver therapeutic effects while minimizing exposure to surrounding tissues.

Clinical research into low-dose radiation therapy for osteoarthritis has expanded significantly over the past decade. Studies have examined treatment protocols for joints including the knee, hip, shoulder and hand, with researchers investigating optimal dose ranges, fractionation schedules and patient selection criteria. Evidence suggests that low-dose radiation can modulate inflammatory pathways in arthritic joints, potentially offering relief when conventional therapies such as physical therapy, anti-inflammatory medications and corticosteroid injections have failed.

Beyond osteoarthritis, radiation therapy has gained traction for treating essential tremor, a neurological disorder affecting millions of people worldwide. Focused radiation techniques can target specific brain structures responsible for tremor generation, offering an alternative to invasive surgical procedures for patients who cannot tolerate or do not respond to medication.

The expansion of radiation therapy into these areas has prompted discussion about treatment protocols, reimbursement frameworks and long-term outcome tracking. Professional societies have begun developing clinical guidelines to standardize care delivery and ensure appropriate patient selection.

Technological improvements in image-guided radiation delivery have been central to these developments. Modern systems integrate advanced imaging capabilities with real-time monitoring, allowing clinicians to visualize target tissues precisely and adjust treatment parameters during delivery. This level of control has made radiation therapy viable for conditions requiring careful dose management and tissue sparing.

As clinical evidence accumulates and regulatory pathways become clearer, radiation therapy for noncancer indications represents a growing segment of therapeutic applications for existing radiotherapy infrastructure.