AI Software Aids Interventional Radiologists during Image-Guided Procedures

Ablation therapy is a minimally invasive treatment that employs extreme temperatures to eliminate abnormal tissue. However, its efficacy is often hampered by imprecise image guidance and treatment control, increasing the risk of complications and recurrence. These challenges have limited its widespread adoption and eligibility among patients. Now, an artificial intelligence (AI)-based system for image-guided ablation therapy has been specifically designed to assist physicians in planning liver ablation procedures and confirming ablation zones, all with the objective of enhancing treatment precision.

VisAble.IO is the first product released by Techsomed Ltd. (Rehovot, Israel) as part of its full BioTrace solution, an end-to-end software solution for full visualization & control for Image Guided Ablation Therapy. By harnessing AI technology, BioTrace leverages standard imaging techniques like ultrasound (US), combined with computed tomography (CT) or magnetic resonance imaging (MRI), to provide real-time visualization of the full extent of the ablation zone. Additionally, it offers intelligent, personalized treatment planning and assessment tools, empowering physicians to provide optimized care tailored to each patient.

VisAble.IO uses advanced computation and image registration to aid physicians in vital aspects of planning and evaluating the ablation coverage for liver tumors. Its standout features include 3D visualization of the ablation target within a patient-specific anatomical view, overlay and positioning of virtual instruments and estimated ablation regions onto medical images, and a unique interactive 3D view of ablation margins and missed volumes, facilitating immediate post-procedure assessment of ablation target coverage.

Techsomed has secured 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO software. The BioTrace platform also encompasses the BioTrace.IO Lite software system, currently undergoing FDA review via the De-Novo pathway following a successful multi-center pivotal trial conducted in the USA. Powered by algorithm-driven technology, BioTrace.IO Lite is set to become the first software device capable of visualizing the ablated area using standard real-time ultrasound imaging.

"We are excited to receive 510(k) clearance for our VisAble.IO solution and appreciate the relentless efforts of our entire team in achieving this milestone. This is a pivotal step forward in our journey of elevating ablation therapy into image guided ablation therapy and making it available for every patient everywhere," said Yossi Abu, CEO and Founder of Techsomed. "The FDA's validation of VisAble.IO's safety and effectiveness not only reflects the exceptional quality of our product but also paves the way for significant commercial opportunities."

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