AARHUS, DENMARK, 12 Dec 2024: Cercare Medical is proud to announce 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 U.S. 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 visualization and analysis of cerebral blood flow dynamics, supporting
healthcare professionals in making fast and accurate diagnoses in critical care situations.
Innovative Capabilities in Stroke Imaging
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.
Cercare Medical’s Vision for Neurological Imaging
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.”
About Cercare Medical:
Cercare Medical is a provider of advanced perfusion imaging solutions. With fully automated and
multi-vendor compatible software for CT and MRI perfusion imaging post-processing, we are committed to delivering cutting-edge technology that enhances patient care and advances medical diagnostics across various neurological conditions, including Stroke, Oncology, Alzheimer's, Dementia, and COVID-19. Our proprietary biomarkers allow for better, more precise imaging maps, improving decision-making in critical care and enhancing neuroimaging. This innovative technology has led to widespread adoption by leading hospitals and clinics around the world.
