Cercare Medical Receives FDA Clearance for Its AI-Powered Perfusion Imaging Solution

CERCARE Perfusion (MRI), an advanced, fully-automated perfusion imaging solution, is now available for the U.S. market

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.

“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.

Clinicians and healthcare systems interested in learning more about CERCARE Perfusion can request a demonstration at https://website.cercare-medical.com/contact-sales/.

For general inquiries reach out to us at www.cercare-medical.com/contact-us/.

“We are very happy to have been among the invited companies and we look forward to forming new partnerships.”

This Corporate Day was promoted by the EIC pilot Business Acceleration Services.

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CLINICAL USE CASES AND TECHNICAL HIGHLIGHTS


CLINICAL USE CASES
  • Assess outcomes post-intervention: detect missed stenoses, distal occlusions, or microvascular disturbances.
  • Guide complementary therapies on the spot based on perfusion status.
  • May detect the no-reflow phenomenon — providing insight into cases where recovery may fail despite successful thrombectomy.
  • Potentially enables direct-to-angio workflows.

TECHNICAL HIGHLIGHTS
  • Full set of perfusion markers: CBF, CBV, MTT.
  • Advanced oxygen metabolism imaging: OEF, CMRO₂.
  • Reliable results with as few as 5 CBCT acquisitions (bolus injection timing protocol very important).
  • Integrated with Siemens and Philips systems; GE/Canon under evaluation.

CBCT Imaging

Side-by-side comparison: The left-hand side is the raw CBCT data, while the right-hand side panel is the pre-processed data.
Using CMN software in the angio suite delivers results comparable to conventional CT/MR perfusion.

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Perfusion Summit 2026
Date: 26 March 2026, Thursday
Time: 10:15 - 17:40 (CET)
Venue: Concorde Hall, Hilton Paris Hotel, CDG
Participation is Optional

Hands-On Workshops
Date: 27 March 2026

Workshop selection is optional and does not confirm registration. Confirmation and further details will be provided in January 2026. Please note that seating is limited.
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