Cercare Receives FDA Clearance for CBCT Perfusion and Collaborates With Siemens on Acute Stroke Care

May 29, 2026—Cercare Medical, a developer of neuroimaging software, announced FDA 510(k) clearance for the company’s Cone-Beam CT Perfusion (CBCT-P) solution, which is intended to enable qualitative perfusion assessment directly from cone-beam CT data acquired during neurointerventional procedures. The CBCT-P solution is based on Cercare Medical’s Vascular Model technology, which currently supports MRI and CT perfusion imaging, noted Cercare.

The company advised that FDA clearance is supported by a multireader, multicase clinical study conducted at Inselspital—Bern University Hospital—in Bern Switzerland, where 13 neuroradiologists independently evaluated perfusion maps from acute stroke patients as part of the validation process. Previously, the solution has received CE Mark approval under the European Medical Device Regulation.

According to the company, the CBCT-P solution for acute stroke imaging brings advanced perfusion analysis into the angio suite, allowing clinicians to assess brain tissue in real time during and immediately after thrombectomy procedures. With Cercare’s CBCT-P technology, clinicians can generate CT-quality perfusion maps directly from standard C-arm systems while the patient remains on the treatment table.

Cercare Medical stated its solution provides established perfusion parameters including relative cerebral blood flow, relative cerebral blood volume, mean transit time, and time-to-maximum, along with advanced physiological biomarkers such as oxygen extraction fraction, capillary transit-time heterogeneity, and cerebral metabolic rate of oxygen. Together, these maps offer clinicians deeper insight into tissue viability and microvascular reperfusion at the point of care.

In a separate press release, Cercare Medical and Siemens Healthineers announced a global collaboration to accelerate the adoption of CBCT-P in acute stroke care and leverage its capability to show the flow of blood through the brain’s tissue and visualize how well different areas are being supplied with oxygen and nutrients.

According to the companies, the joint solution combines the Cercare Neurosuite (CMN) and Siemens Healthineers’ Syngo DynaCT Multiphase:

• CMN is an integrated portfolio of vendor-neutral imaging software solutions that delivers automated perfusion analysis across CT, MRI, and CBCT.
• Syngo DynaCT Multiphase is a three-dimensional acquisition protocol that enables up to ten CBCT angiography phases.

The two solutions combine advanced perfusion and metabolic imaging directly in the angiography suite to help clinicians diagnose stroke and, during intervention, reduce the need of transferring the patient from the angiography room to the imaging modality, stated the companies.