SonoClear is an acoustic coupling fluid that reduces image artefacts in ultrasound imaging.
Using Saline or Ringer as coupling fluid in large resection cavities may create artifacts that reduces the ultrasound image quality. The noise that occur, often at the bottom of resection cavities, is seen as unwanted brightness below the resection cavity in the images above. We are working closely with leading surgeons to solve this problem.
SonoClear reduces image artefacts by mimicking the physical properties of brain tissue.
SonoClear has been used in a Phase 1 clinical trial enrolling 15 patients. A significant improvement of image quality was observed with SonoClear.
– Prof. Geirmund Unsgård, former Head of Neurosurgery Department at St. Olavs Hospital, Trondheim, Norway.
Sonoclear AS develops an acoustic coupling fluid for use in ultrasound guided intraoperative procedures, aiming to enhance the ultrasound image quality. The goal is to provide surgeons with improved decision support, ultimately to improve patient health.
1. Quality commitment:
It is the policy and commitment for Sonoclear AS and its employees to design, develop and manufacture high quality and safe products. SonoClear management ensures this commitment through communication of their policy, trainings in the quality procedures and regular reviews of the quality policy.
2. Quality standard:
We are committed to comply with all applicable quality management system (QMS) and regulatory requirements.
3. Quality improvement:
By close cooperation with our customers, stakeholders, research partners and suppliers, we will continuously strive to improve the quality and value of our products.
Design according to ISO13485
Our quality management system is developed according to ISO13485:2016 Medical device. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.