Cercare Medical announced FDA clearance for its CT perfusion imaging software, a significant milestone that complements the existing clearance for MRI perfusion imaging. This achievement underscores Cercare Medical’s commitment to advancing cerebral perfusion analysis and enhancing stroke care in the US market.
This latest FDA clearance extends the capability of Cercare Medical’s CMN (Cercare Medical
Neurosuite) software package, enabling clinicians to process and analyze CT perfusion images with high levels of precision and efficiency. Designed to run on standard off-the-shelf or virtual platforms, the software facilitates visualisation and analysis of cerebral blood flow dynamics, supporting healthcare professionals in making fast and accurate diagnoses in critical care situations.
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The CMN software now provides advanced perfusion maps for both CT and MRI imaging, offering clinicians a comprehensive tool for assessing brain tissue affected by acute stroke. For CT imaging, the software calculates key parameters such as relative Cerebral Blood Flow (rCBF) threshold volume, Tmax threshold volume, and Mismatch Ratio. These measurements are crucial for identifying areas of ischemic tissue and distinguishing salvageable from irreversibly damaged brain tissue.
By visualizing decreased perfusion—reflected as areas of lower signal intensity for CBF and CBV (Cerebral Blood Volume), and higher signal intensity for Tmax and MTT—the software delivers actionable insights that guide timely and targeted treatment decisions for stroke patients.
This FDA clearance marks a pivotal moment in Cercare Medical’s mission to empower clinicians with cutting-edge imaging tools. With the ability to deliver fully automated solutions for both CT and MRI perfusion imaging, Cercare Medical is now equipped to serve the U.S. market with advanced imaging technology that transforms stroke care and other neurological diagnostics.
“This milestone demonstrates our dedication to advancing precision in neurological imaging,” said Mikkel Bo Hansen, Chief Scientific Officer at Cercare Medical. “By expanding our capabilities to CT imaging, we’re taking further steps in our journey aimed at providing clinicians with the tools they need to make critical decisions faster and with greater confidence.”
