FDA Clears Enhanced MRI-Guided Laser Ablation System
An alternative to an open neurosurgical approach, the Visualase V2 MRI-Guided Laser Ablation System reportedly utilizes laser interstitial thermal therapy (LITT) for targeted soft tissue ablation in patients with brain tumors and focal epilepsy.
The Food and Drug Administration has granted 510(k) clearance for the Visualase V2 MRI-Guided Laser Ablation System, a minimally invasive alternative for performing soft tissue ablation in patients with radiation necrosis, focal epilepsy, or brain tumors.
Through a small 4 mm incision, physicians can utilize the Visualase V2 system for targeted delivery of laser interstitial thermal therapy, which facilitates soft tissue ablation with MRI guidance in neurosurgical procedures, according to Medtronic, the manufacturer of the Visualase V2 system.
Recently cleared by the FDA, the Visualase V2 MRI-Guided Laser Ablation System enables minimally invasive soft tissue ablation in patients with brain tumors, focal epilepsy or radiation necrosis. (Image courtesy of Medtronic.)
Offering enhanced precision and visualization, Medtronic said the Visualase V2 system features updated software and hardware to foster improved workflow efficiencies.
“This clearance is a significant advancement for patients and clinicians alike,” said Ashwini Sharan, M.D., the chief medical officer of Medtronic Neuromodulation. “By providing a minimally invasive option with real-time MRI guidance, we're enhancing surgical precision. This is an important advancement for neurosurgical procedures.”
Recent Videos
Related Content
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025Article
While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.
Study: AI-Generated ADC Maps from MRI More Than Double Specificity in Prostate Cancer Detection
June 5th 2025Article
Emerging research showed that AI-generated ADC mapping from MRI led to significant increases in accuracy, PPV and specificity in comparison to conventional ADC mapping while achieving a 93 percent sensitivity for PCa.
Possible Real-Time Adaptive Approach to Breast MRI Suggests ‘New Era’ of AI-Directed MRI
June 3rd 2025Article
Assessing the simulated use of AI-generated suspicion scores for determining whether one should continue with full MRI or shift to an abbreviated MRI, the authors of a new study noted comparable sensitivity, specificity, and positive predictive value for biopsies between the MRI approaches.
Can Abbreviated MRI Have an Impact in Differentiating Intraductal Papilloma and Ductal Secretion?
June 3rd 2025Article
For patients with inconclusive ultrasound results, abbreviated breast MRI offers comparable detection of intraductal papilloma as a full breast MRI protocol at significantly reduced times for scan acquisition and interpretation, according to a new study.
