Techsomed announced it received FDA 510(k) clearance to expand indications for its BioTraceIO360 software platform to include percutaneous ablation of soft tissue in the kidney.
The company said the clearance advances its development of a multi-organ, hardware-agnostic image-guided therapy platform designed to standardize minimally invasive care from planning through verification. The system had previously been cleared for liver applications.
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Techsomed designed BioTrace to help physicians plan and simulate ablation zones before procedures, guide and adapt treatment during procedures with quantitative feedback, and verify and document coverage after treatment.
“This clearance is a pivotal step toward making interventional oncology a precise, reproducible science,” CEO Yossi Abu said in a news release. “Extending BioTraceIO360 from liver to kidney lays the foundation for a unified multi-organ platform that gives physicians greater precision, consistency, and confidence.”
The company said BioTraceIO360 is now available in the U.S. for both liver and kidney ablation workflows.
“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, associate professor of radiology at Dartmouth Hitchcock Medical Center. “Our interventional radiologists are already seeing value from BioTrace, and this milestone creates even more opportunity to enhance patient care.”
