SonoClear System Gets FDA Breakthrough Device Designation for Enhancing Ultrasound-Guided Brain Tumor Resection

News
Article

The acoustic coupling fluid and sterile transfer kit reportedly removes acoustic artifacts that can occur with the use of standard irrigation fluids in ultrasound-guided neurosurgical interventions.

The Food and Drug Administration (FDA) has issued a breakthrough device designation for the SonoClear System, an acoustic coupling fluid and sterile transfer kit that improves the clarity of intraoperative ultrasound in brain tumor surgery.

In contrast to the use of standard irrigation fluids that commonly obscure tumor remnants at the base of a resection cavity, the SonoClear System provides tissue-mimicking properties that facilitate the removal of acoustic artifacts, according to SonoClear, the developer of the system.

SonoClear System Gets FDA Breakthrough Device Designation for Enhancing Ultrasound-Guided Brain Tumor Resection

Here one can intraoperative ultrasound images showing the obscuring of residual tumor and healthy tissue at the base of a resection cavity (left) and use of the SonoClear System (right), which offers improved clarity for imaging revealing a residual tumor. (Images courtesy of SonoClear.)

SonoClear maintained that the removal of acoustic artifacts with the SonoClear System enables improved confirmation of complete tumor removal with intraoperative ultrasound.

"Toward the end of a resection, with SonoClear fluid in the cavity, I could clearly see whether there was any tumor remnant, which is not always the case when we use standard irrigation fluids as a couplant. This gives me confidence that I can achieve a maximum safe resection using intraoperative ultrasound combined with the SonoClear System,” noted Francesco DiMeco, M.D., the director of neurological surgery at the Neurological Institute Carlo Besta in Milan, Italy, and professor neurosurgery in the Department of Oncology and Hemato-oncology at the University of Milan.

Recent Videos
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
Radiology Study Finds Increasing Rates of Non-Physician Practitioner Image Interpretation in Office Settings
Addressing the Early Impact of National Breast Density Notification for Mammography Reports
Where the USPSTF Breast Cancer Screening Recommendations Fall Short: An Interview with Stacy Smith-Foley, MD
A Closer Look at MRI-Guided Transurethral Ultrasound Ablation for Intermediate Risk Prostate Cancer
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Nina Kottler, MD, MS
Radiology Challenges with Breast Cancer Screening in Women with Breast Implants
Related Content
© 2025 MJH Life Sciences

All rights reserved.