SonoClear Receives FDA Breakthrough Device Designation for Intracranial Ultrasound System

SonoClear AS, a spin-off from Norway’s Ultrasound and Image-Guided Therapy Centre, has received FDA Breakthrough Device designation for its SonoClear system—an acoustic coupling fluid for intracranial ultrasound procedures. Engineered to match brain tissue acoustics, the sterile, biocompatible fluid reduces imaging artifacts caused by standard irrigation fluids, enhancing tumor visibility during neurosurgery.

Designed to improve diagnostic accuracy in intraoperative ultrasound (ioUS), the system may aid surgeons in identifying tumor margins more precisely, potentially improving resection outcomes and reducing the need for repeat procedures. Backed by a successful investment round, SonoClear is now advancing toward FDA 510(k) submission and clinical evaluations.

The device is not yet available for sale but is intended for use in ultrasound-guided brain tumor surgeries to support more informed, real-time surgical decisions and better patient outcomes.

08-07-2025