FDA OKs Techsomed’s BioTraceIO360 for Kidney Ablation

Techsomed, a company specializing in artificial intelligence (AI)-driven precision for image-guided care, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance expanding indications for its BioTraceIO360 software platform to include percutaneous ablation of soft tissue in the kidney.

The milestone advances the company’s plan for a multi-organ, hardware-agnostic image-guided therapy (IGT) platform that standardizes minimally invasive care from planning through verification. BioTraceIO360 is already cleared for the liver.

Minimally invasive, image-guided ablation can provide a nephron-sparing alternative to surgery that’s gaining adoption among interventional teams.

The software allows clinicians to plan and simulate ablation zones before the procedure. During the procedure, the surgeon is guided and adapted with quantitative feedback. Coverage can be verified and documented 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,” added 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.”