Medtronic secures FDA approval for the Visualase V2 MRI-linked laser ablation device
ClearPoint Prism Neuro Laser Therapy System Gains FDA Approval for Neurosurgical Procedures
In the rapidly evolving field of neurosurgery, a significant advancement has been made with the ClearPoint Prism Neuro Laser Therapy System, developed by ClearPoint Neuro in partnership with Clinical Laserthermia Systems (CLS). This MRI-guided laser interstitial thermal therapy (LITT) system has recently been approved by the Food and Drug Administration (FDA) for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy under MRI guidance at a wavelength of 1064nm.
The ClearPoint Prism system, currently cleared for use under 3.0 Tesla MRI guidance, is set to expand its labeling to include 1.5 Tesla MRI guidance, with expected clearance in the second half of 2025. This expansion would unlock over 50% of the US neuro LITT market currently inaccessible with the existing clearance.
Meanwhile, in a separate development, Medtronic has received 510(k) clearance from the U.S. FDA for its Visualase V2 MRI-Guided Laser Ablation System. The Visualase platform, which offers a minimally invasive surgical option for patients with focal epilepsy, brain tumors, and radiation necrosis, provides proven precision, accuracy, and enhanced visualization capabilities.
The Visualase system offers several patient benefits, including reduced hospital stays, faster recovery, minimal scarring, lower risk of infection, and high patient satisfaction. Dr. Ashwini Sharan, chief medical officer of Medtronic Neuromodulation, stated that this clearance is a significant advancement for patients and clinicians.
In the realm of neurosurgery, innovation continues to drive progress. While ClearPoint Neuro is making strides with its ClearPoint Prism Neuro Laser Therapy System, no specific new FDA-approved MRI-guided LITT system by Medtronic has been identified in the latest updates.
Here's a summary of the current FDA-approved MRI-guided LITT systems for neurosurgical procedures as of mid-2025:
| System | Manufacturer | FDA Status (2025) | MRI Guidance | Indications | |--------------------------------------------------|----------------------------|------------------------------------------------------------|--------------|------------------------------------------| | ClearPoint Prism Neuro Laser Therapy System | ClearPoint Neuro + CLS | Approved for 3.0T MRI; 1.5T MRI clearance expected H2 2025 | 3.0T / 1.5T | Necrotizing/coagulating soft tissue in neurosurgery via LITT | | No new Medtronic-specific MRI-guided LITT system | Medtronic (no recent update) | Not identified or newly approved in 2025 | N/A | N/A |
As the field of neurosurgery continues to evolve, it's exciting to see these advancements that aim to improve patient outcomes and push the boundaries of what's possible.
[1] Source: ClearPoint Neuro press release, 2025.
Digital health advancements in neurosurgery are exemplified by the FDA approval of the ClearPoint Prism Neuro Laser Therapy System for neurosurgical procedures. Additionally, science and medical-conditions related to neurosurgery, health-and-wellness, and therapies-and-treatments benefit from innovations like the MRI-guided laser interstitial thermal therapy (LITT) system.
