Techsomed’s VisAble.IO Software Receives FDA Clearance for Planning and Confirmation in Liver Ablation Therapy

September 29, 2023—Techsomed Ltd., an Israel-based medical software developer focused on ablation therapy, announced recently that it received 510(k) clearance from the FDA for its VisAble.IO software. VisAble.IO is intended to assist physicians in planning liver ablation procedures and confirming ablation zones, with the goal of increasing treatment precision.

According to the company, the software is intended to address the shortcomings of ablation therapy, in which insufficient image guidance, precision, and treatment control have led to a high risk of recurrence and complications, creating significant barriers to widespread adoption and limiting patients’ eligibility.

Techsomed noted that VisAble.IO employs advanced computation and image registration to assist physicians in crucial steps of planning and assessing the ablation coverage of liver tumors. Key features include three-dimensional (3D) visualization of the ablation target within a patient-specific anatomic view; overlay and position of virtual instruments and estimated ablation regions onto medical images; and an interactive 3D view of ablation margins and missed volumes to help assess ablation target coverage immediately postprocedure.

“There is a real need for a good and efficient assessment tool, and it can serve any physician performing thermal ablations,” commented Ryosuke Tateishi, MD, in Techsomed’s press release. Dr. Tateishi is from the Department of Gastroenterology at the University of Tokyo in Tokyo, Japan.

VisAble.IO is the first product released as part of Techsomed’s full BioTrace solution, which is an end-to-end software solution for full visualization and control for image-guided ablation therapy.

The company stated that BioTrace uses artificial intelligence-based technology to leverage standard imaging—such as ultrasound along with CT or magnetic resonance imaging—to provide visualization of the full extent of the ablation zone in real-time, together with smart, personalized treatment planning and assessment tools, allowing physicians to provide their patients with optimized care.

The full BioTrace platform also includes the BioTrace.IO Lite software system, which is currently under review by the FDA through the de novo pathway, after the completion of a multicenter pivotal trial conducted in the United States.

With its algorithm-powered technology, BioTrace.IO Lite will provide visualization of the ablated area based on standard real-time ultrasound imaging. The BioTrace.IO solution is not yet approved for sale or distribution in the United States, where it is limited by law to investigational use, advised the company.

In October 2022, TechsoMed announced the completion of patient enrollment in the United States pivotal trial evaluating the safety and effectiveness of BioTraceIO Lite. The trial enrolled 50 patients at six clinical sites in the United States. Sadeer Alzubaidi, MD, an interventional radiologist with Mayo Clinic Arizona in Phoenix, Arizona, is the trial’s principal investigator.