Why MRgFUS Matters to Clinicians

MRgFUS enables treatment of deep brain targets without opening the skull, implanting hardware, or exposing patients to radiation. Guided by real-time MRI, it offers sub-millimeter accuracy, immediate therapeutic benefit, and rapid recovery.

For the right patients, it can be the difference between hesitation and hope — providing durable outcomes with fewer risks compared to invasive procedures.

MRgFUS Timeline: Key Clinical &
Regulatory Milestones

July 2016
First MRI-guided Focused Ultrasound device approved for treating Essential Tremor (medication-refractory).
December 2018
Expanded indication for Tremor-Dominant Parkinson’s Disease (TDPD).
November 2021
Expanded to cover other Parkinson’s symptoms including bradykinesia, rigidity, and dyskinesia.
August 2022
Five-year follow-up confirms sustained tremor relief and improved quality of life (JNS, 2022).
January 2023
Staged bilateral treatments permitted for Essential Tremor (second side).
July 2025
Exablate Neuro approved for staged bilateral pallidothalamic tractotomy in advanced Parkinson’s Disease.
India – CDSCO Approval
MRgFUS cleared for treating neuropathic pain, expanding access for Indian patients.

Clinical Evidence & Indications

Essential Tremor (ET)

G. Rees Cosgrove et al., JNS 2022 –

  • 73.3% tremor improvement at 5 years.
  • Functional disability scores remained significantly improved.
  • Conclusion: Unilateral MRgFUS thalamotomy delivers durable tremor relief
    with no delayed or progressive complications.

Elias et al., NEJM 2016 –

  • Class I evidence, randomized controlled trial.
  • 71% tremor improvement at 3 months, sustained at 12 months.
  • Regulatory Status: FDA-approved for medication-refractory ET since 2016.

Parkinson’s Disease (PD)

JAMA Neurology 2021 –

  • Demonstrated significant reduction in tremor, rigidity, and dyskinesia after MRgFUS pallidotomy or sub-thalamotomy.
  • Regulatory Status: FDA-approved (2021) for unilateral treatment of Parkinsonian tremor in advanced disease.

FDA Approval 2025 –

  • Exablate Neuro cleared for staged bilateral pallidothalamic tractotomy in advanced PD.
  • Expands options for severe, bilateral motor symptoms previously managed only with invasive approaches.

Get access to peer-reviewed data, global approvals, and key clinical outcomes.

Download Clinical Evidence Dossier

Emerging Indications (Research & Trials)

Global research is advancing MRgFUS applications to:

epilepsy
Epilepsy
obsessive-compulsive-disorder
Obsessive-Compulsive Disorder (OCD)
depression
Depression
addiction
Addiction
neuropathic-pain
Neuropathic Pain (CDSCO approved in India)
oncology-applications
Oncology applications (e.g., targeted tumor ablation, metastatic bone pain relief)

Early adopters are well positioned to lead in these future breakthroughs.

Patient Selection Criteria

Ideal Candidates:

  • Asymmetrical motor symptoms (e.g., unilateral tremor, rigidity, or dyskinesia).
  • Older patients at higher risk for invasive surgery.
  • Patients unable to tolerate general anesthesia (awake MRgFUS procedure).
  • MRI compatible (no contraindicating implants, claustrophobia manageable).
  • Skull Density Ratio ≥ 0.4 (for optimal ultrasound transmission).

When MRgFUS is Especially Valuable:

  • Co-morbidities (e.g., cardiac, pulmonary) making invasive surgery unsafe.
  • Immunosuppression, coagulation disorders, or active infection — where wound healing is compromised.
  • Marginal cognitive impairment — safe for MRgFUS but unsuitable for implant- dependent therapies.
  • Patients hesitant or fearful of surgery — incision-free therapy improves acceptance.
  • Challenges in long-term follow-up or implant management — e.g., remote geographies, reluctance for DBS adjustments.

Treatment Workflow

  • Evaluate – Neurological consultation, imaging, and SDR analysis.
  • Plan – Target identification (thalamus, pallidum, or tractotomy sites).
  • Treat – Incremental sonications under MRI, with continuous patient feedback.
  • Recover – Same-day discharge possible, improvement often visible during the procedure.

Advantages for Clinicians

  • Incision-Free – No infection, bleeding, or wound-related complications.
  • Real-Time MRI Precision – Sub-millimeter targeting with thermal monitoring.
  • Patient-Friendly – Awake, outpatient procedure with minimal downtime.
  • Evidence-Based – Backed by randomized trials, 5-year data, FDA/CE approvals, and CDSCO clearance in India.

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