BioTraceIO Precision
World's first FDA-cleared software for tissue response prediction in ablation therapy
Company profile
Company profile
TechsoMed is a global medical imaging software company specializing in AI-powered image-guided ablation therapy (IGAT) systems for cancer treatment. Founded in 2015 and headquartered in Or-yehuda, Israel, the company addresses critical challenges in minimally invasive oncology procedures where more than half of treatments fail to completely eliminate cancerous tissue. The company's flagship BioTraceIO360 platform represents the world's first FDA-cleared software for tissue response prediction in tumor ablation. The platform compresses thousands of imaging frames into one actionable interface, providing physicians with 360-degree intelligent visualization throughout the entire ablation workflow—from pre-procedure planning through real-time monitoring to post-treatment verification. BioTrace delivers risk-aware 3D modeling, smarter needle path planning, real-time margin visualization, in-procedure tumor coverage assessment, and predictive tissue response analysis. The system is vendor-agnostic and integrates with standard medical imaging modalities including ultrasound, CT, and MRI. TechsoMed has received multiple FDA clearances, including De Novo clearance for tissue response prediction and 510(k) clearances for liver and kidney ablation applications. The company operates subsidiaries in Germany (in partnership with Fraunhofer Mevis) and Japan, and has established strategic partnerships with major healthcare technology companies including Medtronic, GE HealthCare, and Lenovo. TechsoMed's mission extends beyond current applications, with a roadmap targeting expansion into embolization therapy, radiation therapy, cryoablation, pain management, and cardiovascular ablation to make intelligent minimally invasive solutions accessible to patients everywhere.
Company description TechsoMed official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
On Premise deployment with recorded integration context.
Recorded integration context: CT imaging systems, GE HealthCare Logiq ultrasound systems, MRI systems, Standard ultrasound systems.
Company milestones
FDA 510(k) clearance for kidney ablation (September 2025), strategic collaboration with Medtronic announced (October 2025), partnership with Hadassah Medical Center for AI-driven radiotherapy (July 2025), U.S. launch of BioTraceIO Vision and BioTraceIO Precision (July 2024)
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
World's first FDA-cleared software for tissue response prediction in ablation therapy
FDA-cleared software for image-guided ablation therapy planning and monitoring
Full-cycle ablation management platform with AI-driven insights for precise tumor margin control
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · Dec 1, 2026
Retrospective evaluation of a novel ultrasound-based imaging analysis software for predicting radiofrequency ablation areas.PloS one · Jan 1, 2025
Clinical validation
No linked records are currently available.
Regulatory
K251931 · 510k · Sep 8, 2025
VisAble.IOK240773 · 510k · Apr 15, 2024
VisAble.IOK223639 · 510k · Aug 28, 2023
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Real-time monitoring during ablation procedures
AI-driven insights for precise tumor margin assessment
Addressing >50% failure rate in complete tumor elimination
Expanding use of AI-driven image-guided therapy platform for interventional radiology procedures including kidney ablation
Interventional radiologists seeing value from BioTrace platform
Strategic pilot collaboration to advance next generation of minimally invasive image-guided therapies targeting tumor radiotherapy, leveraging extensive imaging datasets and clinical expertise
Positioning Hadassah as a Center of Excellence for AI-driven image-guided therapy
Field evaluation of BioTrace.IO 360 using GE HealthCare's Logiq ultrasound systems at top USA clinical sites
Field evaluation of BioTrace.IO 360 using GE HealthCare's Logiq ultrasound systems
Optimizing treatment outcomes in ablation therapy
System described as 'key to optimizing treatment outcomes' after a few months of use
Comprehensive ablation process management from planning to post-treatment evaluation
First comprehensive product covering entire ablation process observed by clinician
Enhanced visualization and decision support during ablation procedures
System provides additional clinical oversight described as 'having another set of eyes'
05 · Leadership
Leadership profiles and professional links from the current Company record.
06 · Company updates
Recent articles published on TechsoMed's official website.
07 · HAIC coverage
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No HAIC coverage is currently linked to this Company.
08 · Official presence
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09 · Market pathway
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Market context
Companies developing surgical technologies enhanced by AI, including robotic surgical systems, AI-powered surgical assistance and navigation tools, autonomous surgical robotics, and surgical data and analytics platforms. Covers both the performance of surgery and the analysis of surgical outcomes and OR efficiency.
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