Bracco Imaging and medical device company BURL Concepts have teamed up to improve ischemic stroke detection and patient care.
The exclusive partnership will see Bracco manufacture a microbubble solution that will be used with BURL Concepts’s SONAS device, a portable system designed for non-invasive brain perfusion assessment.
Already in clinical use in Germany, the SONAS device offers a portable, cost-effective solution for assessing ischemic strokes, among other conditions.
The CE Mark-certified technology is expected to improve patient care by enabling rapid diagnosis and monitoring in various settings, from pre-intervention diagnostics to post-intervention bedside monitoring.
With more than 350 patients already tested using the SONAS device for a range of clinical indications, the technology has proven its utility in early stroke detection and treatment monitoring.
The partnership between Bracco and BURL Concepts is set to further enhance the device’s impact on stroke care.
BURL Concepts has submitted the SONAS IDE application to the US Food and Drug Administration (FDA).
The Center for Devices and Radiological Health (CDRH) is reviewing the application.
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The company anticipates launching FDA trials in early 2025 to launch the technology to a broader market.
BURL Concepts CEO and chief medical officer Thilo Hoelscher said: “This collaboration allows us to leverage Bracco’s microbubble technology exclusively as part of the SONAS system, which will enhance our ability to provide accurate and timely assessment of cerebral perfusion.
“We believe this partnership can significantly improve patient outcomes and set a new standard in brain monitoring and specifically in stroke care.”
Last year, the European Commission granted market authorisation to Bracco Imaging’s Vueway (gadopiclenol), a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging.