SonoClear AS Receives FDA Breakthrough Designation for SonoClear® System

-  Innovative Fluid Designed to Assist in Ultrasound-Guided Surgical Resection of Brain Tumors -

-  First Fully Norwegian Owned Company to be Granted Breakthrough Device Designation -

OSLO, Norway, July 1, 2025 /PRNewswire/ -- SonoClear AS today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has designated the SonoClear^® System as a Breakthrough Device for use in intracranial ultrasound procedures.

The SonoClear System is an acoustic coupling fluid and sterile transfer kit, engineered to address a critical limitation of conventional intraoperative imaging during neurosurgical interventions. The SonoClear System's tissue-mimicking properties remove the acoustic artifacts that appear when using standard irrigation fluids as a couplant and which typically obscure critical tumor remnants at the base of a resection cavity. The SonoClear System was developed, and is wholly owned, by SonoClear, a company founded to improve diagnostic accuracy in ultrasound-guided interventions.

"Removing aggressive neurological tumors, such as gliomas, presents a significant surgical challenge," said Prof. Geirmund Unsgaard, neurosurgeon and SonoClear founder. "In brain tumor surgery, neurosurgeons rely on intraoperative ultrasound to guide their work and confirm complete tumor removal. Standard irrigation fluids create visual artifacts that can obscure the surgical site precisely when clarity is most critical: at the end of the procedure when surgeons need to verify whether any tumor remains. We created a simple solution that works with all intraoperative ultrasound systems and allows neurosurgeons to clearly see the tumor, enabling improved decision-making in surgery."

SonoClear recently closed an oversubscribed investment round. The company is sufficiently funded to support final product testing and clinical evaluations required for the FDA 510k submission, as well as market conditioning activities in the U.S. and Europe upon regulatory clearance.

SonoClear's CEO, Peter Balmforth, commented, "With breakthrough designation, the FDA recognizes a select number of devices with the potential to positively impact patients facing life-threatening conditions. We are encouraged by early phase I data, which demonstrated SonoClear System's ability to deliver improved image clarity. We are currently conducting additional clinical investigations to evaluate SonoClear System against the current standard of care. Our team is energized to finalize the 510k submission and bring this product one step closer to giving neurosurgeons real-time, high-definition image quality to better guide tumor resection."

Prof. Francesco DiMeco, neurosurgical specialist at the Neurological Institute Carlo Besta in Italy, world-renowned intraoperative ultrasound expert, and a principal investigator in studies of the SonoClear System, said, "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."

About the SonoClear® System

SonoClear System is an ultrasound acoustic coupling fluid for intracranial ultrasound procedures. It is biocompatible, bio-excretable, sterile, and unit-dose packaged. Its initial intended use is in intracranial ultrasound-guided surgical tumor resection. SonoClear System was engineered to match the acoustic properties of brain tissue. This minimizes the bright signal artifacts and enhanced echogenicity that conventional irrigation fluids create, and which typically obscure ultrasound imaging in surgical cavities. Studies demonstrate that using SonoClear System with ioUS enhances the diagnostic accuracy of intraoperative imaging, potentially improving the extent of resection (EOR) and reducing residual disease. The device is not yet available for sale.

About the Market Need

Neurosurgical resection remains the primary treatment modality and standard of care for brain tumors, requiring precise intraoperative decision-making to optimize patient outcomes. Skilled neurosurgeons rely on high-quality imaging to make critical determinations about tumor margins and resection boundaries. Intraoperative ultrasound (ioUS) provides real-time imaging and is widely available, yet its diagnostic accuracy is compromised by suboptimal imaging conditions. Standard irrigation fluids like saline (0.9%) and lactated Ringer's solution create acoustic artifacts and image quality variability because they were not designed for diagnostic optimization. These imaging constraints limit the clarity needed for precise tumor margin identification, hindering surgeons' ability to make optimal treatment decisions based on what they can visualize in the resection cavity. By improving the diagnostic accuracy of ioUS, an enhanced ultrasound acoustic coupling fluid would have the potential to support better surgical decision-making, contributing to improved survival outcomes, significantly delayed tumor recurrence, and reduced healthcare costs by helping minimize the need for repeat surgeries and adjunctive treatments.

About SonoClear AS

SonoClear was spun out of the Ultrasound and Image-Guided Therapy Centre in Trondheim, Norway to develop technology that improves diagnostic accuracy in ultrasound-guided interventions. The company has the support of majority shareholders SINTEF, Sarsia, CoFounder and Sparebank 1 SMN, along with family offices and private investors. For more information, please visit https://www.sonoclear.no.

CONTACTS

Peter Balmforth 
CEO
[email protected] 

Media:
Amy Martini 
Martini Communications 
[email protected] 
917-664-1538 

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SOURCE SonoClear AS