Cercare Medical, a specialist in advanced neuroimaging software, has received US Food and Drug Administration (FDA) 510(k) clearance (K253831) for its Cone-Beam CT (CBCT) Perfusion solution.

The software enables clinicians to perform qualitative brain perfusion assessments directly from cone-beam CT data acquired during neurointerventional procedures.

The clearance represents a significant advancement in acute stroke imaging, allowing healthcare professionals to assess brain tissue in real time within the angiography suite during and immediately following thrombectomy procedures.

Traditionally, advanced perfusion imaging requires stroke patients to be moved between imaging systems and treatment rooms, adding complexity and time to critical care pathways. Cercare Medical's CBCT Perfusion technology aims to streamline this process by generating CT-quality perfusion maps directly from standard C-arm imaging systems while patients remain on the treatment table.

The solution provides established perfusion parameters, including regional cerebral blood flow (rCBF), regional cerebral blood volume (rCBV), mean transit time (MTT), and Tmax. In addition, it delivers advanced physiological biomarkers such as oxygen extraction fraction (OEF), capillary transit time heterogeneity (CTH), and cerebral metabolic rate of oxygen (CMRO2), offering clinicians deeper insights into tissue viability and microvascular reperfusion.

"FDA clearance of Cone-Beam CT Perfusion represents a major milestone not only for Cercare Medical, but potentially for the future of stroke workflows," said Mikkel Bo Hansen, Chief Scientific Officer at Cercare Medical. 

"From a scientific and regulatory perspective, the clearance also validates a completely new approach to intra-procedural perfusion imaging and tissue assessment,” Hansen added further.

Henrik Andersen, Chief Commercial Officer at Cercare Medical said, “We are already seeing very significant interest from both clinicians and industry partners globally. Stroke centers are actively looking for technologies that can simplify workflows, reduce patient transfers, and support faster treatment decisions in time-critical settings.”