VisAble.IO

by Techsomed  · Based in Israel → — AI-Powered Image-Guided Ablation Therapy for Enhanced Precision
Interventional Radiology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

VisAble.IO is an advanced AI-powered software solution developed by Techsomed, designed to assist physicians in the precise planning and confirmation of ablation zones during liver and kidney ablation procedures. As a key component of Techsomed’s BioTrace platform, VisAble.IO integrates with standard medical imaging modalities such as ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) to provide real-time visualization and personalized treatment planning.

The software aims to increase treatment precision by offering comprehensive visualization and control for image-guided ablation therapy, thereby addressing challenges related to insufficient image guidance and treatment control that can lead to high recurrence rates and complications. VisAble.IO supports critical steps from pre-procedure planning and simulation to intra-procedure guidance with quantitative feedback, and post-procedure verification and documentation of ablation coverage.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D visualization of ablation target within a patient-specific anatomical view
  • Overlay and positioning of virtual instruments and estimated ablation regions onto medical images
  • Interactive 3D views of ablation margins and missed volumes for immediate post-procedure assessment
  • AI-based image-guided ablation therapy system
  • Leverages standard imaging modalities: ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI)
  • Real-time visualization of the full extent of the ablation zone
  • Advanced computation and image registration for precise planning and assessment
  • Assists in planning and assessing ablation coverage of liver and kidney tumors

Use Cases

  • Planning liver ablation procedures
  • Confirming ablation zones in liver ablation procedures
  • Assessing ablation coverage immediately post-procedure for liver and kidney tumors
  • Image-guided thermal ablation therapy in oncology (liver and kidney tumors)
  • Enhancing precision and control in minimally invasive ablation treatments
  • Supporting interventional radiologists in image-guided procedures

What Physicians Need to Know

Key Capabilities
Assists physicians in planning liver ablation procedures and confirming ablation zones. Provides 3D visualization of ablation targets, virtual instrument overlay, and interactive 3D views of ablation margins and missed volumes. Utilizes AI-based technology, advanced computation, and image registration, leveraging standard imaging modalities like ultrasound, CT, and MRI. It is part of Techsomed's BioTrace platform for image-guided ablation therapy.
Clinical Utility
Aims to increase treatment precision in liver ablation procedures and helps assess ablation target coverage immediately post-procedure. It aids in identifying ablation targets and virtual ablation needle placement, addressing challenges of insufficient image guidance precision and treatment control.
Integration Options
Imports images from CT scanners and facility PACS systems. It is compatible with all ablation devices for treatment confirmation functions. VisAble.IO complements Techsomed's BioTrace.IO, forming a comprehensive image-guided ablation visualization framework, and Techsomed is collaborating with Medtronic for integration with their microwave ablation systems.
Compliance Status
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for planning liver ablation procedures, classifying it as a Class II medical device. It complies with 21 CFR Part 820.30 (Design Control process), FDA 'Guidance on Software Contained in Medical Devices,' and adheres to the DICOM standard.
User Experience
It is controlled by the user via a user interface, with modifications made to improve the user experience.
Implementation Complexity
A stand-alone software application designed for use in the Operating Room and hospital healthcare environments, such as interventional radiology control rooms. It involves distinct workflow steps including data import, anatomical structures segmentation, instrument placement, ablation zone segmentation, and treatment confirmation.
Evidence Base
FDA 510(k) clearance indicates substantial equivalence to a predicate device (Aline Ablation Intelligence) in safety and effectiveness, supported by verification and validation testing. The broader BioTrace.IO platform, which VisAble.IO complements, has been validated in a multi-center USA pivotal study demonstrating superiority in estimating ablation zones compared to immediate post-procedure CECT scans.
Physician Tip

VisAble.IO is a valuable tool for enhancing precision in liver ablation procedures, offering advanced 3D visualization and planning capabilities. Physicians should integrate this software into their pre-procedural planning and immediate post-procedural assessment workflows to optimize ablation target coverage. Remember that the software is intended to assist and confirm, not for diagnosis or prediction of ablation success. Its compatibility with various imaging modalities and ablation devices makes it a flexible addition to interventional radiology practices. Leveraging its integration with BioTrace.IO can provide a more comprehensive image-guided ablation visualization framework.

VisAble.IO is designed to integrate seamlessly with existing clinical infrastructure by importing images from standard CT scanners and PACS systems. Its compatibility extends to various ablation devices for treatment confirmation. For a more complete image-guided ablation solution, it is designed to work in conjunction with Techsomed's BioTrace.IO, which offers real-time tissue response prediction. Future integrations, such as the collaboration with Medtronic, indicate a trend towards broader compatibility with interventional oncology systems.

Details

Category Oncology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentOn-premise/Cloud-based (integrated with CT/MR scanners and PACS systems)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

VisAble.IO received 510(k) clearance (K240773) from the U.S. Food and Drug Administration (FDA) on April 15, 2024, for radiological image processing software for ablation therapy planning and evaluation. It is intended to assist physicians in planning and confirming ablation zones for liver ablation procedures. The BioTrace platform, which includes VisAble.IO, has also expanded its clearance to include kidney ablation.

Integrations
EHR Not specified
Specialties Interventional Radiology, Urology

What the Web Says

VisAble.IO, developed by Techsomed, is an AI-driven software designed to enhance the precision of liver ablation procedures by assisting physicians in planning and confirming treatment. It is part of Techsomed's BioTrace platform, an AI-based image-guided ablation therapy system. The software has received FDA 510(k) clearance and is intended for use by clinicians, radiologists, oncologists, and interventional radiologists.

Overall: Positive

Strengths

  • 3D visualization of ablation targets within patient-specific anatomy.
  • Overlay and positioning of virtual instruments on medical images.
  • Interactive 3D assessment of ablation margins and missed volumes post-procedure.
  • Enhances planning and real-time assessment for liver tumor ablation procedures.
  • Aids in increasing treatment precision.
  • FDA 510(k) clearance for marketing in the U.S.

Limitations

  • No specific cons were found in the provided search results regarding VisAble.IO.
  • Pricing details are not publicly available; users need to contact the vendor for information.

Based on reviews from: HealthAidb, Diagnostic Imaging, AuntMinnie, PR Newswire, Medical Device Network, Applied Radiology, G-MedTech

Last updated: 2026-07-19

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Press & Coverage

AuntMinnie
Techsomed gets FDA nod for VisAble.IO software
Israel-based AI developer Techsomed received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VisAble.IO software, intended for planning liver ablation procedures and confirming ablation zones to increase treatment precision.
2023-09
PR Newswire
Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software
Techsomed Ltd. announced it received 510(k) clearance from the FDA for its VisAble.IO software, which assists physicians in planning liver ablation procedures and confirming ablation zones to enhance treatment precision.
2023-09
Diagnostic Imaging
AI-Powered Liver Tumor Ablation Software Leverages CT, MRI and Ultrasound for Real-Time Image Guidance
The FDA granted 510(k) clearance for VisAble.IO (TechsoMed), an AI-enabled software designed to improve real-time imaging guidance for liver tumor ablation procedures using ultrasound, CT, and MRI.
2023-09
Medical Device Network
FDA approves Techsomed's ablation treatment planning software
The US FDA granted 510(k) clearance for Techsomed's VisAble.IO software, which helps physicians plan liver ablation procedures and confirm ablation zones to enhance treatment precision.
2023-09
Let's Talk Risk!
Medical Device News Update - December 2023
VisAble.IO software from Techsomed Ltd. is intended to analyze images of an ablation zone, primarily in liver ablation procedures, to provide predictive information for post-treatment planning.
2024-01
BioSpace
Techsomed's BioTrace Solution Achieves De Novo Clearance from FDA as the First Ultrasound-Based Software for Tissue Response Prediction in Liver Tumor Ablation
Techsomed's BioTrace.IO, which complements VisAble.IO, received De Novo clearance from the FDA as the first ultrasound-based software for tissue response prediction in liver tumor ablation.
2024-01
Let's Talk Risk!
Medical Device News Update - December 2023
VisAble.IO software from Techsomed Ltd. is a Class II device (Product Code QZL, Regulation 21 CFR 892.2052) intended for analyzing images of an ablation zone in liver ablation procedures to provide predictive information for post-treatment planning.
2024-01
Journal of Digestive Endoscopy
Advancements in Artificial Intelligence-Enhanced Imaging Diagnostics for the Management of Liver Diseaseu2014Applications and Challenges in Personalized Care
VisAble.IO by TechsoMed Medical Technologies Ltd. is listed as an AI-powered tool used to plan liver ablation procedures.
2026-07

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Frequently Asked Questions

VisAble.IO is an AI-powered software developed by Techsomed designed to assist physicians in planning liver ablation procedures and confirming ablation zones. It integrates into the workflow by leveraging standard imaging modalities like ultrasound, CT, or MRI to provide 3D visualization of the ablation target and estimated ablation regions, aiming to increase treatment precision.
VisAble.IO assists with crucial steps in planning and assessing liver tumor ablation coverage. Its key features include 3D visualization of the ablation target within a patient-specific anatomical view, overlaying virtual instruments and estimated ablation regions onto medical images, and providing interactive 3D views of ablation margins and missed volumes for immediate post-procedure assessment.
Yes, VisAble.IO has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing Techsomed to market the software in the U.S. This clearance signifies that the device is substantially equivalent to a legally marketed predicate device.
While specific details on data privacy protocols for VisAble.IO are not extensively detailed in public releases, as an FDA-cleared medical device handling sensitive patient imaging data, it must adhere to stringent healthcare data privacy regulations like HIPAA. It is part of Techsomed's BioTrace platform, which utilizes AI-based technology with standard imaging, implying secure handling of medical images.
VisAble.IO aims to enhance treatment precision by providing advanced AI-based 3D visualization and planning tools that go beyond traditional image guidance. It offers real-time visualization of the ablation zone and personalized treatment planning, which can reduce the risk of recurrence and complications often associated with insufficient image guidance precision.
Like all AI tools, VisAble.IO's effectiveness relies on the quality and representativeness of the data it was trained on, which could introduce biases if not diverse enough. Physicians must still exercise their clinical judgment as the software is intended to assist, not replace, human decision-making.
Physicians retain full responsibility for patient care and treatment decisions, even when utilizing AI-powered tools like VisAble.IO. The software is a decision-support tool, and the physician's expertise and judgment remain paramount in interpreting the AI's output and executing the procedure.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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