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# Medtronic receives FDA clearance for Visualase V2 MRI-guided laser ablation system
- URL: https://med-techinsights.com/medtronic-receives-fda-clearance-for-visualase-v2-system/
- Published: 2025-06-09T08:28:57.000Z
- Updated: 2026-10-22T08:35:29.000Z
- Description: Medtronic has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Visualase V2 MRI-Guided Laser Ablation System. This milestone brings important capital system enhancements to the Visualase platform, which provides a minimally invasive surgical option
- Author: Oliver Johnson
- Tags: Medical Device Manufacturing, News

[**Medtronic**](https://www.medtronic.com/uk-en/index.html?ref=med-techinsights.com) has announced it has received 510(k) clearance from the [**U.S. Food and Drug Administration**](https://www.fda.gov/?ref=med-techinsights.com) (FDA) for its Visualase V2 MRI-Guided Laser Ablation System. This milestone brings important capital system enhancements to the Visualase platform, which provides a minimally invasive surgical option for patients with focal epilepsy, brain tumors, and radiation necrosis, which impacts over 1 million people total worldwide.

Visualase allows surgeons to navigate deep within the brain with pinpoint accuracy, gently delivering laser energy to ablate diseased tissue without disturbing surrounding structures. This is done through an incision just millimeters wide. Visualase uses laser interstitial thermal therapy (LITT) to deliver precisely targeted energy through a small catheter, enabling surgeons to ablate soft tissue under real-time MRI guidance. Compared to traditional open neurosurgery, the Visualase system offers several patient benefits:

- Minimally invasive access through a small (4 mm) incision
- Reduced hospital stays and faster recovery
- Minimal scarring
- Lower risk of infection
- High patient satisfaction

“This clearance is a significant advancement for patients and clinicians alike,” said Dr. Ashwini Sharan, chief medical officer of Medtronic Neuromodulation, which is part of the Neuroscience Portfolio. “By providing a minimally invasive option with real-time MRI guidance, we’re enhancing surgical precision. This is an important advancement for neurosurgical procedures.”

The V2 offers proven precision, accuracy, and enhanced visualisation capabilities, now with completely redesigned software, hardware, and interface for a more intuitive, streamlined, and efficient workflow. It is also designed to easily unlock future innovations that are expanding what’s possible in LITT without needing to upgrade any hardware.