July 2025 The U.S. FDA approved a PMA supplement for Insightec's Exablate Neuro (Model 4000), expanding its labeling to include staged unilateral pallidothalamic tractotomy for medication-refractory Parkinson's disease. The approval broadens the clinical use of MRI-guided focused ultrasound neurosurgical ablation.
May 2025 The U.S. FDA granted 510(k) clearance to Medtronic Navigation's Visualase™ V2 MRI-Guided Laser Ablation System. The updated system incorporates software and hardware enhancements for MRI-guided laser interstitial thermal therapy (LITT) used in minimally invasive neurosurgical procedures. This represents one of the most significant regulatory developments in the MRI-guided neurosurgical ablation market during the period.
May 2025 Researchers introduced FUAS-Agents, an autonomous AI-assisted treatment planning framework for MRI-guided focused ultrasound ablation, demonstrating the increasing integration of AI into pre-procedural planning and workflow optimization.
2025 Clinical researchers reported growing adoption of MRI-guided laser interstitial thermal therapy (LITT) for treating epilepsy, primary brain tumors, and metastatic brain lesions due to its minimally invasive approach, MRI thermometry, and reduced recovery time.