Techsomed Receives FDA 510(k) Clearance Expanding BioTraceIO360 Platform to Kidney Ablation Advancing a Unified Multi-Organ Image-Guided Therapy Platform

TEL AVIV, Israel, Sept. 22, 2025 /PRNewswire/ -- Techsomed, a leader in AI-Driven Precision for Image-Guided Care, today announces U.S. FDA 510 (k) clearance expanding indications for BioTraceIO360* software platform to include percutaneous ablation of soft tissue in the kidney, in addition to its previously cleared liver application. The milestone advances Techsomed's vision for a multi-organ, hardware-agnostic image-guided therapy (IGT) platform that standardizes minimally invasive care from planning through verification.

Kidney cancer affects roughly ~82,000** people In the United States each year. For carefully selected patients, minimally invasive, image-guided ablation offers a nephron-sparing alternative to surgery that is gaining adoption among interventional teams.

What BioTraceIO360 enables

• Plan & simulate ablation zones pre-procedure
• Guide & adapt intra-procedure with quantitative feedback
• Verify & document coverage to support consistent outcomes

"We're encouraged by Techsomed's new FDA clearance and look forward to expanding our use of its AI-driven image–guided therapy platform," said Dr. Eric Hoffer MD, Associate Professor of Radiology Dartmouth Hitchcock Medical Center

"Our interventional radiologists are already seeing value from BioTrace, and this milestone creates even more opportunity to enhance patient care."

"This clearance is a pivotal step toward making interventional oncology a precise, reproducible science," said Yossi Abu, CEO of TechsoMed. "Extending BioTraceIO360 from liver to kidney lays the foundation for a unified multi-organ platform that gives physicians greater precision, consistency, and confidence."

Availability
BioTraceIO360 is available in the U.S. for liver and kidney ablation workflows. For demonstrations, clinical documentation, and compatibility details, visit techsomed.com/biotrace.

About Techsomed
Techsomed is an Image-Guided Therapy software company advancing AI-powered, hardware-agnostic solutions that unify planning, execution, and verification for minimally invasive procedures. Founded in 2015, TechsoMed operates in Israel, Germany, and Japan.

Media contact:
Shira Doron, Marketing Director — [email protected] 

Regulatory Disclaimer
BioTraceIO360* has received U.S. FDA 510(k) clearance for the percutaneous ablation of soft tissue in the liver and kidney. Refer to labeling for full indications, contraindications, warnings, and instructions for use.

Footnote:

* The BioTraceIO360 solution comprises the BioTraceIO Vision and BioTraceIO Precision software products, both have been FDA-cleared for marketing in the U.S.

** https://www.cancer.org/cancer/types/kidney-cancer/about/key-statistics.html#:~:text=About%2081%2C610%20new%20cases%20of%20kidney%20cancer,4%2C940%20women)%20will%20die%20from%20this%20disease. 

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SOURCE Techsomed