SonoClear Neurosurgical Ultrasound Tool Earns FDA Breakthrough Nod

SonoClear announced that the U.S. Food and Drug Administration (FDA) has awarded breakthrough device status to its SonoClear system for intracranial ultrasound procedures.

The acoustic coupling fluid and sterile transfer kit was designed to address a limitation of conventional intraoperative imaging during neurosurgical interventions. Its tissue-mimicking properties remove acoustic artifacts that show up when using standard irrigation fluids as a couplant and which usually obscure tumor remnants at the base of a resection.

The company also recently disclosed an oversubscribed investment round. SonoClear said it’s sufficiently funded to support final product testing and clinical evaluations needed for FDA 510(k) submission, as well as market conditioning activities in the U.S. and Europe upon regulatory clearance.

“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.”

The company is the first fully Norwegian-owned firm to be granted Breakthrough Device Designation.

“With breakthrough designation, the FDA recognizes a select number of devices with the potential to positively impact patients facing life-threatening conditions,” added SonoClear CEO Peter Balmforth. “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.”