FDA clears Techsomed BioTraceIO360 for kidney ablation

Techsomed this week 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.

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.”

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