SonoClear System Receives FDA Breakthrough Device Designation for Brain Tumor Surgery

SonoClear AS has announced that the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has granted Breakthrough Device designation to the SonoClear® System. 

The device is designed for use in intracranial ultrasound procedures and aims to enhance imaging during brain surgery.

The SonoClear System includes an acoustic coupling fluid and a sterile transfer kit. It is developed to overcome a major issue found with traditional intraoperative imaging methods.

Standard irrigation fluids often create acoustic artefacts that interfere with ultrasound images, especially towards the end of tumor removal procedures. 

These artefacts can make it difficult to detect small tumour remnants, particularly at the base of the resection cavity. The SonoClear fluid mimics tissue properties, helping to provide clearer images during surgery.

The product is fully developed and owned by SonoClear AS, a company focused on improving accuracy in ultrasound-guided medical procedures.

The removal of aggressive brain tumors, such as gliomas, is a challenging surgical task. In these procedures, surgeons commonly rely on ultrasound to help guide them and check for complete tumour removal. 

The SonoClear System is designed to be compatible with all existing intraoperative ultrasound platforms and offers improved visual clarity at critical moments during surgery.

SonoClear recently completed a successful funding round, which will support final product testing, clinical studies, and regulatory activities. 

The Breakthrough Device designation is given to products that have the potential to offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. 

This recognition by the FDA may allow SonoClear to benefit from an accelerated review process, helping to bring the system to clinical use more quickly.