Techsomed, a leader in AI-Driven Precision for Image-Guided Care, 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.
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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.”
Source: PRNewswire