Aarhus, Denmark (May 31, 2021) – At Cercare Medical we are proud to announce that our advanced perfusion imaging solution, CERCARE Perfusion (MRI), has now received FDA 510(k) clearance by the U.S. FDA. The solution embodies more than 20 years of research in perfusion and tissue viability. The result is state-of-the-art images of perfusion markers including capillary blood volume and flow. Moreover, based on many years of research we are now also able to produce images representative of oxygen delivery and utilization using only standard clinical imaging sequences. The solution is fully automated enabled by artificial intelligence and therefore solidifies imaging diagnostics while helping to increase workflow efficiency in radiology departments.
CERCARE Perfusion was created in response to the rising importance of perfusion imaging for routine patient management in a wide range of diseases. Yet existing solutions would be limited to a few imaging parameters not covering the full range of indicators on a capillary function level such as oxygen extraction capacity. They often also involve manual steps which compromise speed and reproducibility. Cercare Medical has combined many years of innovative research with practical requirements such as automation, ease of use, and flexible integration into a unique solution now available in the United States.
“We are very excited to introduce the MRI module of CERCARE Perfusion to the U.S. market,” said Mikkel Bo Hansen, co-founder and Chief Scientific Officer at Cercare Medical. “Several U.S. healthcare institutions already use CERCARE Perfusion in their research in brain tumors, acute ischemic stroke, and neurodegenerative disease. With this FDA approval, our solution can now be fully implemented in the clinical workflow helping to save time while deepening the radiological assessment of patients with vascular disorders and capillary pathology.”
The solution runs on the hardware already used in the radiology setting or via a 3rd party platform. It uses standard DICOM files and is compatible with major scanner manufacturers and PACS providers.