Techsomed Medical Technologies LTD announces that the U.S. FDA has granted De Novo clearance for BioTraceIO, an ultrasound-based liver ablation software designed to assist physicians during liver tumor ablations.

Ablation therapy, a minimally invasive treatment using extreme temperatures, has lacked ultrasound-based prediction tools until now. BioTraceIO employs a computational algorithm to analyze ultrasound images captured during liver ablation treatment. During the procedure, the software offers real-time display and registration of the Reference Ablation Zone, using technical parameters provided by ablation device manufacturers.

Post-procedure, it provides a visual display of the estimated ablation zone, correlating with findings from 24-hour contrast-enhanced CT (CECT) scans. This predictive information is clinically beneficial, as it aligns with the observed increase in ablation zone volume at 24 hours post-procedure.

According to Nami Azar, MD, professor of radiology at the University Hospitals Cleveland Medical Center and principal investigator in the BioTraceIO pivotal study: “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. 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.”

The performance of BioTraceIO underwent rigorous validation in a multi-center study involving 50 patients. The results demonstrated its accuracy in estimating the ablation zone as visualized in 24-hour CECT scans, providing information about size and shape based solely on ultrasound imaging that correlates with CT information.

BioTrace.IO works with Techsomed’s VisAble.IO, an AI-powered tool for planning and confirming ablation treatments. Together, they form an advanced image-guided system, minimizing uncertainty in thermal ablation therapy.

“Techsomed has taken a major step towards making our vision for image guided ablation therapy a reality,” says Yossi Abu, Techsomed’s CEO and founder. “The FDA’s De Novo clearance is game changing as we gear up to commercialize both BioTrace.IO and VisAble.IO across multiple market segments in the U.S. We are genuinely excited to be able to offer physicians smart solutions that bring a new level of precision to ablation therapy.”