The FDA has granted 510(k) clearance to the BioTraceIO360 software platform for use in percutaneous ablation of soft tissue in the kidney, Techsomed announced in a news release.1
BioTraceIO360 is an image-guided therapy platform.
BioTraceIO360 is an image-guided therapy platform designed to standardize minimally invasive care from treatment planning through verification. This clearance adds onto the previous indication for the BioTraceIO platform for use in liver tumor ablation.2
“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 Eric Hoffer, MD, an associate professor of radiology at Dartmouth Hitchcock Medical Center in New Hampshire, in the news release.1 “Our interventional radiologists are already seeing value from BioTrace, and this milestone creates even more opportunity to enhance patient care.”
According to Techsomed, The BioTraceIO360 platform enablessurgeons to “plan and simulate ablation zone pre-procedure, guide and adapt [during the procedure] with quantitative feedback, and verify and document coverage to support consistent outcomes.”
“This clearance is a pivotal step toward making interventional oncology a precise, reproducible science,” said Yossi Abu, CEO of TechsoMed, in the news release.1 “Extending BioTraceIO360 from liver to kidney lays the foundation for a unified multi-organ platform that gives physicians greater precision, consistency, and confidence.”
Previous Clearance of BioTraceIO360
The BioTraceIO360 platform was previously granted de novo clearance in January 2024 as a liver ablation software designed for tissue response prediction.
The clearance was supported by data from a multicenter pivotal trial (NCT04970212) in which the BioTraceIO360 software demonstrated superiority to immediate post-procedure contrast-enhanced CT (CECT) scans in estimating the ablation zone at the time of 24-hour CECT, when the maximum ablation zone expansion is observed. Notably, the BioTraceIO360 software was able to “accurately predict the ablation zone as visualized 24 hours post-procedure, providing information about size and shape based solely on ultrasound imaging that correlates with CT information,” Techsomed added.
In total, the study included 50 patients enrolled through clinical trial sites in the US.
The BioTraceIO platform is designed to be integrated with Techsomed’s VisAbleIO platform, which is an AI-powered product for treatment planning and confirmation for thermal ablation therapy.
REFERENCES
1. Techsomed receives FDA 510(k) clearance expanding BioTraceIO360 platform to kidney ablation advancing a unified multi-organ image-guided therapy platform. News release. Techsomed. September 22, 2025. Accessed September 22, 2025. https://www.prnewswire.com/news-releases/techsomed-receives-fda-510k-clearance-expanding-biotraceio360-platform-to-kidney-ablation-advancing-a-unified-multi-organ-image-guided-therapy-platform-302562887.html
2. Techsomed’s BioTrace solution achieves de novo clearance from FDA as the first ultrasound-based software for tissue response prediction in liver tumor ablation. News release. Techsomed. January 8, 2024. Accessed September 22, 2025. https://www.prnewswire.com/news-releases/techsomeds-biotrace-solution-achieves-de-novo-clearance-from-fda-as-the-first-ultrasound-based-software-for-tissue-response-prediction-in-liver-tumor-ablation-302028369.html