Designed to reduce imaging artifacts during neurosurgery, the SonoClear System is now moving toward 510(k) submission.
SonoClear AS announced that the Center for Devices and Radiological Health (CDRH) of the US 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 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.
“Removing aggressive neurological tumors, such as gliomas, presents a significant surgical challenge,” says Geirmund Unsgaard, MD, PhD, neurosurgeon and SonoClear founder, in a release. “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.”
Advancing Toward Market Readiness
SonoClear recently closed an oversubscribed investment round. The company says it is sufficiently funded to support final product testing and clinical evaluations required for the FDA 510(k) submission, as well as market conditioning activities in the US and Europe upon regulatory clearance.
SonoClear’s CEO, Peter Balmforth, says in a release, “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, intraoperative ultrasound expert, and a principal investigator in studies of the SonoClear System, adds in a release, “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.”
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