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September 22, 2025

Techsomed’s BioTraceIO360 Platform Cleared for Kidney Ablation Indication 

September 22, 2025—Techsomed, a developer of image-guided therapy software, announced FDA 510(k) clearance of an expanded indication for the company’s BioTraceIO360 software platform to include percutaneous ablation of soft tissue in the kidney, in addition to its previously cleared liver application.

According to the company, BioTraceIO360 enables physicians to plan and simulate ablation zones preprocedure, guide and adapt intraprocedure with quantitative feedback, and verify and document coverage to support consistent outcomes.

BioTraceIO360 is now available in the United States for liver and kidney ablation workflows, advised the company.

Further, the press release noted that the milestone advances Techsomed’s aim for a multiorgan, hardware-agnostic, image-guided therapy platform that standardizes minimally invasive care from planning through verification.

“We’re encouraged by Techsomed’s new FDA clearance and look forward to expanding our use of its artificial intelligence-driven image-guided therapy platform,” commented Eric Hoffer, MD, in the company’s press release. Dr. Hoffer, Associate Professor of Radiology at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, added, “Our interventional radiologists are already seeing value from BioTrace, and this milestone creates even more opportunity to enhance patient care.”

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Bentley’s BeFlared FEVAR Bridging Stent System Granted FDA Breakthrough Device Designation 

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Sentante Stroke System Receives FDA Breakthrough Device Designation


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