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FDA Grants De Novo Clearance for Ultrasound-Based Liver Tumor Ablation Software


The BioTraceIO software reportedly facilitates visualization of liver tumor ablation procedures based on real-time ultrasound imaging and provides superior post-op estimates of ablation zone volume in comparison to computed tomography.

The Food and Drug Administration (FDA) has granted De Novo clearance for the ultrasound-based BioTraceIO, a software that offers enhanced post-op estimates of tissue response after liver tumor ablation procedures.

Employing a unique computational algorithm, BioTraceIO (Techsomed) assesses real-time ultrasound images and utilizes technical parameters of the ablation device’s manufacturer to provide clinicians with registration of the reference ablation zone.

Techsomed said the software subsequently provides an immediate post-op visual estimate of liver tumor ablation on tissue response. A multicenter study found that BioTraceIO offered superior ablation zone estimates of tissue response at 24 hours in comparison to post-op contrast-enhanced computed tomography (CECT), according to Techsomed.

"Imaging plays a crucial role in tumor ablation. While ultrasound serves as a cost-efficient and patient-friendly option for real-time visualization, there is a potential for enhanced visualization and continuous monitoring of the ablation tissue response,” noted Nami Azar, M.D., a professor of radiology in the Department of Radiology within the School of Medicine at Case Western Reserve University in Cleveland. “BioTraceIO opens new possibilities in utilizing ultrasound for liver ablation procedures. I am excited to witness its impact in action and the advancements it brings to our field.”

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