SonoClear System Accepted for FDA Review
News related to:SonoClear AS · 1 min read
OSLO, Norway, Oct. 21, 2026 /CourierPR/ -- SonoClear AS has taken a significant step toward making its innovative SonoClear® System available to U.S. neurosurgeons. The company announced that its 510(k) submission for the SonoClear® System, an acoustic coupling fluid designed to improve intraoperative ultrasound imaging during brain tumor procedures, has been accepted for substantive review by the U.S. Food and Drug Administration (FDA).
Peter Balmforth, CEO of SonoClear AS, expressed optimism about the progress.
The SonoClear System is engineered to reduce acoustic artifacts within the resection cavity, thereby providing a clearer view and enhancing surgical decision-making. Data from a pivotal 44-patient study, recently presented at the 2026 annual congress of the European Association of Neurosurgical Societies, demonstrated that the system met the primary and secondary safety endpoints. Additionally, the study indicated an improvement in overall image quality compared to standard irrigation fluids.
Professor Francesco DiMeco, a Professor of Neurosurgery at the University of Milan and Director of the Department of Neurological Surgery at the Carlo Besta Neurological Institute, presented the findings.
SonoClear AS was spun out of the Ultrasound and Image-Guided Therapy Centre in Trondheim, Norway, with the mission to develop technology that improves diagnostic accuracy in ultrasound-guided interventions. The company has received support from majority shareholders including SINTEF Venture IV, Sarsia, CoFounder and Sparebank 1 SMN, along with family offices and private investors.
The SonoClear System is a sterile, biocompatible, and bio-excretable ultrasound acoustic coupling fluid designed for use during brain tumor resections. It is engineered to match the acoustic properties of brain tissue, thereby reducing the bright signal artifacts and visual noise caused by conventional irrigation fluids. By providing a clearer view of the surgical cavity, the system may enhance diagnostic accuracy, potentially improving the extent of tumor resection and reducing residual disease.
The company's next steps will involve the FDA's substantive review of the 510(k) submission. If cleared, the SonoClear System will be available to U.S. neurosurgeons, potentially transforming the way brain tumor surgeries are conducted.