SonoClear® System 510(k) Submission Accepted for FDA Review

OSLO, Norway, Oct. 21, 2026 /PRNewswire/ -- SonoClear AS today announced that its 510(k) submission for the SonoClear^® System, an innovative acoustic coupling fluid, has been accepted for substantive review by the U.S. Food and Drug Administration (FDA). FDA clearance would allow the company to market the system in the United States, where it previously was granted Breakthrough Device Designation.

"Acceptance of this submission brings us an important step closer to our goal of making the SonoClear System available to U.S. neurosurgeons," said Peter Balmforth, SonoClear CEO. "Our aim is to give surgeons a clearer view of the surgical cavity to support decision-making in certain types of brain tumor surgery."

The SonoClear System is designed to improve intraoperative ultrasound imaging during brain tumor procedures by reducing acoustic artifacts within the resection cavity to support clearer visualization and enhanced surgical decision-making.

Data from the pivotal 44-patient study recently were presented at the 2026 annual congress of the European Association of Neurosurgical Societies by Professor Francesco DiMeco, Professor of Neurosurgery at the University of Milan and Director of the Department of Neurological Surgery at the Carlo Besta Neurological Institute in Milan. In this study, SonoClear met the primary and secondary safety endpoints, and the system delivered an indication of improvement in overall image quality compared with standard irrigation.

Balmforth continued, "There was considerable excitement around the pivotal trial data presented earlier this month at the EANS Congress. We collected feedback from future users of the SonoClear technology and anticipate a strong opportunity as we proceed toward commercialization."

About the SonoClear^® System

The SonoClear System is a sterile, biocompatible, bio-excretable ultrasound acoustic coupling fluid designed for use during brain tumor resections. It is engineered to match the acoustic properties of brain tissue, to reduce 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 SonoClear System has been granted Breakthrough Device Designation by the United States Food and Drug Administration. This investigational product is not authorized for sale or distribution.

About SonoClear AS

SonoClear AS was spun out of the Ultrasound and Image-Guided Therapy Centre in Trondheim, Norway to develop technology to improve diagnostic accuracy in ultrasound-guided interventions. The company has the support of majority shareholders SINTEF Venture IV, Sarsia, CoFounder and Sparebank 1 SMN, along with family offices and private investors.

For more information, please visit www.sonoclear.no.

Contacts

Peter Balmforth, CEO
[email protected]

Media: Amy Martini, Martini Communications
[email protected]

SOURCE SonoClear AS