FDA Expands Clearance of Ultrasound-Based Software for Percutaneous Soft Tissue Ablation in the Kidney

The Food and Drug Administration (FDA) has granted an expanded clearance of the BioTraceIO360 (Techsomed) ultrasound-based software for use in soft tissue ablation in the kidney.

Techsomed said key attributes of the BioTraceIO360 software include:

• pre-procedure planning and simulation for ablation zones;

• quantitative feedback for intra-procedure guidance; and

• appropriate documentation and verification of coverage to promote consistency in outcomes.

Facilitating minimally invasive image guidance for percutaneous soft tissue ablation in the kidney, the BioTraceIO360 was previously cleared by the FDA for liver tumor ablation therapy, according to Techsomed.

"This clearance is a pivotal step toward making interventional oncology a precise, reproducible science," said Yossi Abu, the 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."