FDA Clears Cone-Beam CT Software for Real-Time Qualitative Perfusion Assessment

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Cone-Beam CT (CBCT) Perfusion software, which offers real-time intraoperative brain tissue assessments during thrombectomy procedures.

The Cone-Beam CT Perfusion software provides CT-quality perfusion mapping from standard C-arm platforms, according to Cercare Medical, the developer of the software. In addition to evaluation of perfusion parameters such as relative cerebral blood flow (rCBF), mean transit time (MTT) and time-to-maximum (Tmax), the company noted the Cone-Beam CT Perfusion software also offers assessment of physiological biomarkers, including oxygen extraction fraction (OEF), cerebral metabolic rate of oxygen (CMRO) consumption and capillary transit time (CTH).

Cercare Medical emphasized that the real-time capabilities of the Cone-Beam CT Perfusion software enable clinicians to see perfusion deficits, missed distal occlusions and incomplete reperfusion prior to leaving the OR.

"The possibility of obtaining advanced perfusion imaging directly in the angio suite opens entirely new perspectives for both clinicians and patients, including future direct-to-angio workflows where selected patients may potentially bypass conventional pre-treatment imaging steps. From a scientific and regulatory perspective, the clearance also validates a completely new approach to intra-procedural perfusion imaging and tissue assessment,” noted Mikkel Bo Hansen, the founder and chief scientific officer at Cercare Medical.