FDA grants real-time liver ablation AI approval
The U.S. Food and Drug Administration has granted De Novo clearance for Techsomed’s BioTraceIO, which uses a computational algorithm to analyze ultrasound images captured during liver ablation treatment for use with its artificial intelligence-powered ablation treatment platform.
WHY IT MATTERS
Ablation treatment methods, such as radiofrequency ablation, microwave ablation, and cryoablation, are alternative first-line treatments for patients with unresectable primary and secondary liver tumors. Although used safely, complications can occur because ablation zones can expand over 24 hours until stabilized, affecting blood vessels, bile ducts, and other structures.
Real-time image-guided ablation can help doctors strategically remove liver lesions by providing visualization of the ablated area based on standard ultrasound, Techsomed said in its announcement Monday.
The company said the artificial intelligence analysis successfully predicted tissue response in a validated multicenter study involving 50 patients with liver tumors, demonstrating BioTraceIO’s superiority over standard post-procedure contrast-enhanced CT scans in estimating of the final ablation zone.
“Imaging plays a critical role in tumor ablation,” said Dr. Nami Azar, professor of radiology at University Hospitals Cleveland Medical Center and lead investigator on the study, said in a statement.
“While ultrasound is a cost-efficient and patient-friendly option for real-time visualization, there is potential for improved visualization and continuous monitoring of ablation tissue response,” Azar said.
THE BIG TREND
AI analytics, coupled with real-time ultrasound, delivers precision to a range of medical diagnoses and treatment procedures, such as 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, said 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, helping clinicians see better imaging in the hospital.
“This type of AI feedback has clear immediate benefits for patient care as an accurate diagnosis can be made,” he said Healthcare IT news in 2022.
“However, the long-term impact of direct AI feedback could be even greater.”
In 2023, AI innovation increased every month.
In February, the FDA approved enhanced applications such as Clarius Mobile Health’s AI ultrasound application for musculoskeletal imaging. In November, many healthcare technology companies presented newly available AI tools at the Radiological Society of North America conference. For example, Konica Minolta Healthcare Americas, together with its academic partners, presented research on the launch of dynamic digital radiography technology and machine learning for imaging and clinical decision support.
ON THE RECORD
Yossi Abu, CEO and founder of Techsomed, said in a statement that the FDA approval was groundbreaking.
“Techsomed has taken a major step toward realizing our vision for image-guided ablation therapy,” said Abu.
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.