FDA Approves Bilateral Ultrasound for Parkinson's Disease

The procedure treats symptoms by using ultrasound waves to create precise lesions in the brain.

Updated on Oct. 27, 2026 in Stroke

A metallic focused ultrasound helmet sits on a clean white clinical table in a bright, minimalist medical laboratory. — The FDA has approved the use of bilateral magnetic resonance-guided focused ultrasound to treat motor symptoms like tremors and rigidity in Parkinson's disease. AI Illustration. Upload story photo >

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In July 2025, the FDA approved staged bilateral magnetic resonance-guided focused ultrasound to treat Parkinson's disease symptoms. This approval follows clinical trials demonstrating that the procedure can address issues like tremors, rigidity, and dyskinesia.

Why it matters

Abnormal signaling in the pallidothalamic tract drives core Parkinson's symptoms, and this targeted intervention offers a non-invasive option for patients. Medicare began covering the procedure in March 2026, improving access for those with the condition.

A multicenter clinical trial recruited 54 patients, with 40 individuals completing the bilateral treatment process. Results indicate that 86% of patients experienced improvement three months after their second procedure.

The players

FDA

The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of medical devices and treatments.

NewYork-Presbyterian/Weill Cornell Medical Center

This major academic medical institution served as a clinical trial site for testing the efficacy of bilateral focused ultrasound.

University of Maryland School of Medicine

This institution acted as a co-lead research partner in evaluating the application of focused ultrasound technology for movement disorders.

The details

Patients undergo the treatment while wearing a specialized helmet inside an MRI machine, which allows doctors to monitor brain temperatures during the process. The focused ultrasound waves create a precise lesion on a deep brain pathway to interrupt the abnormal signals causing motor dysfunction.

2016: FDA approved focused ultrasound for essential tremor.
2018: FDA approved focused ultrasound for Parkinson's tremors.
2021: FDA expanded approval for Parkinson's mobility issues.
July 2025: FDA approved staged bilateral treatment.
March 2026: Medicare began covering bilateral focused ultrasound.

Health Landscape

This technological advancement follows years of regulatory progression and reflects the integration of precise neurological interventions into standard Medicare coverage policies. The adoption of this procedure signals a shift toward non-invasive neurosurgery for the 1 million Americans living with Parkinson's.

Patients may now access bilateral treatment covered by Medicare to address symptoms like rigidity and slow movement. Potential candidates should be aware that the procedure carries risks involving speech, walking, and balance issues.

The takeaway

While 86% of clinical trial participants reported improvement, the procedure is specifically designed to target pathways deep in the brain that cause motor symptoms. Patients should consult with specialized neurologists to determine if they are suitable candidates given the potential risks to speech and balance.