Techsomed's BioTrace Solution Achieves De Novo Clearance from FDA as the First Ultrasound-Based Software for Tissue Response Prediction in Liver Tumor Ablation
REHOVOT, Israel , Jan. 8, 2024 /PRNewswire/ -- Techsomed Medical Technologies LTD is thrilled to announce that FDA has granted De Novo clearance for its BioTraceIO, a groundbreaking ultrasound-based liver ablation software - designed for Tissue Response Prediction.
REHOVOT, Israel , Jan. 8, 2024 /PRNewswire/ -- Techsomed Medical Technologies LTD is thrilled to announce that FDA has granted De Novo clearance for its BioTraceIO, a groundbreaking ultrasound-based liver ablation software - designed for Tissue Response Prediction. As the first and only FDA-cleared solution of its kind, BioTraceIO is designed to aid physicians performing liver tumor ablations by providing visualization of the ablated area based on standard real-time ultrasound imaging.
Ablation therapy, a minimally invasive treatment leveraging extreme temperatures, currently does not have tools available to predict the effect of ablation based on ultrasound. BioTraceIO utilizes a unique computational algorithm to analyze ultrasound images captured during liver ablation treatment.
During the procedure, the software provides real-time display and registration of the Reference Ablation Zone (RAZ) using technical parameters provided by the ablation device's manufacturers. Upon procedure's completion, it offers a visual display of the estimated ablation zone, correlating with that seen in 24-hour contrast-enhanced CT (CECT). This predictive information is clinically beneficial as it is known from literature that a significant increase in the ablation zone volume is observed at 24 hours at which time it is also stabilized.
Dr. Nami Azar, 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 has been rigorously validated in a multi-center USA pivotal study involving 50 patients. The results demonstrate its superiority to immediate post-procedure CECT scans in estimating the ablation zone as seen in 24-hour CECT at which time maximum ablation zone expansion is observed. Significantly, the software accurately predicts the ablation zone as visualized 24 hours post-procedure, providing information about size and shape based solely on ultrasound imaging that correlates with CT information
BioTrace.IO 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", stated 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.
About Techsomed
Techsomed is a global medical imaging software company dedicated to making an enhanced clinical impact in oncology, cardiology and pain management through the first Generative AI powered image guided ablation therapy system. The company focuses on leveraging standard medical imaging (ultrasound, CT, MRI) for generating real-time ablation visualization, advanced patient-specific treatment planning and predictive procedure analysis to ensure high-precision ablation that is accessible to a wide range of patients.
Techsomed contact:
Edith Schlanger
Marketing Manager
[email protected]
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