Ablation therapy, a minimally invasive treatment that employs extreme temperatures, presently lacks the tools to predict the impact of ablation based on ultrasound. Imaging plays a vital role in tumor ablation. Although ultrasound serves as a cost-efficient and patient-friendly option for real-time visualization, there exists potential for improving visualization and continuously monitoring the response of the ablation tissue. Now, a groundbreaking software can aid physicians conducting liver tumor ablations by offering visualization of the ablated area based on standard real-time ultrasound imaging.

BioTraceIO from Techsomed Medical Technologies (Rehovot, Israel) is an ultrasound-based software for tissue response prediction in liver tumor ablation that employs a unique computational algorithm to analyze ultrasound images captured during liver ablation treatment. It offers real-time visualization and tracking of the Reference Ablation Zone (RAZ), utilizing technical data from the ablation device manufacturers. After the ablation procedure, it generates a visual representation of the estimated ablation zone. This visualization is expected to match the results seen in a 24-hour contrast-enhanced CT (CECT) scan. This feature is particularly valuable, given that studies indicate a notable increase in the volume of the ablation zone 24 hours post-procedure, which is when it typically stabilizes.

The efficacy of BioTraceIO has been thoroughly tested and confirmed through a pivotal multi-center study in the USA, involving 50 patients. The study's findings show that BioTraceIO's predictions are more accurate than immediate post-procedure CECT scans in estimating the ablation zone as observed in 24-hour CECT. This is significant because the software can accurately forecast the size and shape of the ablation zone based on ultrasound images alone that correlate with CT information. The FDA has granted De Novo clearance for BioTraceIO which complements Techsomed's VisAble.IO, an AI-powered ablation treatment planning and confirmation product. The integrated solution provides a comprehensive image-guided ablation visualization framework for eliminating guesswork typically associated with thermal ablation therapy.

"Techsomed has taken a major step towards making our vision for image-guided ablation therapy a reality," said 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 USA. We are genuinely excited to be able to offer physicians smart solutions that bring a new level of precision to ablation therapy.” 

http://m.allmycbs.com/en/index.asp