Cercare Medical Receives FDA 510(k) Clearance for Cone-Beam CT Perfusion

Cercare Medical, a leader in advanced neuroimaging software, today announced FDA 510(k) clearance (K253831) for its Cone-Beam CT (CBCT) Perfusion solution, enabling qualitative perfusion assessment directly from cone-beam CT data acquired during neurointerventional procedures. 

The clearance marks an important step forward in acute stroke imaging by bringing advanced perfusion analysis directly into the angio suite, allowing clinicians to assess brain tissue in real time during and immediately after thrombectomy procedures.

Traditionally, advanced perfusion imaging requires moving stroke patients between imaging systems and treatment rooms. With Cercare’s CBCT Perfusion technology, clinicians can now generate CT-quality perfusion maps directly from standard C-arm systems while the patient remains on the treatment table. 

The solution provides established perfusion parameters including rCBF, rCBV, MTT, and Tmax, alongside advanced physiological biomarkers such as OEF, CTH and CMROâ??. Together, these maps offer clinicians deeper insight into tissue viability and microvascular reperfusion at the point of care. 

The technology addresses a significant unmet clinical need in stroke treatment. While successful thrombectomy procedures restore blood flow in major vessels, studies indicate that up to one in three patients experience insufficient microvascular reperfusion - commonly referred to as the “no reflow” phenomenon - despite technically successful recanalization. Conventional angiography cannot visualize these capillary-level perfusion deficits. 

By enabling tissue-level assessment directly inside the angio suite, Cercare’s CBCT Perfusion solution may help clinicians identify persistent perfusion deficits, missed distal occlusions, and incomplete reperfusion before the patient leaves the procedure room.

"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. "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."

Henrik Andersen, Chief Commercial Officer at Cercare Medical, added: "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. We believe the combination of conventional perfusion imaging and Cercare Medical’s advanced biomarkers such as OEF, CTH and CMROâ?? creates a highly differentiated solution with substantial clinical and commercial potential."

The FDA clearance is supported by a multi-reader multi-case clinical study conducted at Inselspital, Bern University Hospital, Switzerland, where 13 neuroradiologists independently evaluated perfusion maps from acute stroke patients as part of the validation process. 

The CBCT Perfusion solution is based on Cercare Medical’s proprietary Vascular Model technology, which already supports MRI and CT perfusion imaging globally. By using the same processing engine across modalities, Cercare Medical delivers consistent and clinically familiar outputs across different imaging environments. 

About Cercare Medical 

Cercare Medical is a provider of advanced perfusion imaging solutions. With fully automated, vendor-neutral software for CT and MRI perfusion post-processing, the company supports clinicians across the world with tools that enhance diagnostics for stroke, oncology, Alzheimer’s disease, and other neurological conditions. Cercare’s proprietary biomarkers and automated pipelines enable better imaging maps, improving speed and confidence in clinical decision-making. 

For more information please visit www.cercare-medical.com or contact: