FDA grants real-time liver ablation AI clearance

The U.S. Food and Drug Administration gave De Novo clearance to Techsomed’s BioTraceIO, which leverages a computational algorithm to analyze ultrasound images captured during liver ablation treatment for use with its artificial intelligence-powered ablation treatment platform.


Ablation treatment methods, like radiofrequency ablation, microwave ablation and cryoablation, are alternative first-line treatments for patients with inoperable primary and secondary liver tumors. While safely used, complications can arise as ablation zones may expand over 24 hours, until they are stabilized, and compromise blood vessels, bile ducts and other structures.

Real-time image-guided ablation can help physicians strategically remove liver lesions by providing visualization of the ablated area based on standard ultrasound imaging, Techsomed said in its announcement Monday.

The company said the artificial intelligence analysis successfully provided tissue-response prediction in a validated multicenter study involving 50 patients with liver tumors, demonstrating BioTraceIO’s superiority to standard post-procedure contrast-enhanced CT scans in estimating the final ablation zone. 

“Imaging plays a crucial role in tumor ablation,” Dr. Nami Azar, professor of radiology at the University Hospitals Cleveland Medical Center and the principal investigator in the study, said in a statement.

“While ultrasound serves as a cost-efficient and patient-friendly option for real-time visualization, there is a potential for enhanced visualization and continuous monitoring of the ablation tissue response,” Azar said.


AI analysis, coupled with real-time ultrasound, is bringing precision to a range of medical diagnoses and treatment procedures, like lung perfusion assessments, to improve patient outcomes and experiences, and improve overall healthcare delivery.

Point-of-care ultrasound devices have made care more accessible in rural and remote areas, but now AI is bridging the gap between imaging and medical analysis, according to Dr. Mark Favot, associate professor and director of emergency ultrasound at the Detroit Receiving Hospital of Emergency Medicine at Wayne State University. 

Robust AI on POCUS machines can provide users with actionable feedback to improve the quality of patient images, so that physicians at the hospital are looking at better imaging. 

“This type of AI feedback has obvious immediate benefits for patient care now that a proper diagnosis can be made,” he told Healthcare IT News in 2022.

“However, the long-term impact of immediate AI feedback might be even more impactful.”

In 2023, AI innovation ramped up with each passing month. 

By February, FDA was already clearing enhanced applications, such as Clarius Mobile Health’s AI ultrasound application for musculoskeletal imaging. In November, many healthcare technology companies showcased newly available AI tools at the Radiological Society of North America conference. For example, Konica Minolta Healthcare Americas presented research alongside its academic partners launching dynamic digital radiography technology and machine learning for imaging and clinical decision support.


Yossi Abu, Techsomed’s CEO and founder, said in a statement that FDA’s clearance was game-changing.

“Techsomed has taken a major step towards making our vision for image-guided ablation therapy a reality,” Abu said.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.


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