- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA Grants De Novo Clearance for Ultrasound-Based Liver Tumor Ablation Software
The BioTraceIO software reportedly facilitates visualization of liver tumor ablation procedures based on real-time ultrasound imaging and provides superior post-op estimates of ablation zone volume in comparison to computed tomography.
The Food and Drug Administration (FDA) has granted De Novo clearance for the ultrasound-based BioTraceIO, a software that offers enhanced post-op estimates of tissue response after liver tumor ablation procedures.
Employing a unique computational algorithm, BioTraceIO (Techsomed) assesses real-time ultrasound images and utilizes technical parameters of the ablation device’s manufacturer to provide clinicians with registration of the reference ablation zone.
Techsomed said the software subsequently provides an immediate post-op visual estimate of liver tumor ablation on tissue response. A multicenter study found that BioTraceIO offered superior ablation zone estimates of tissue response at 24 hours in comparison to post-op contrast-enhanced computed tomography (CECT), according to Techsomed.
"Imaging plays a crucial role in tumor ablation. 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,” noted Nami Azar, M.D., a professor of radiology in the Department of Radiology within the School of Medicine at Case Western Reserve University in Cleveland. “BioTraceIO opens new possibilities in utilizing ultrasound for liver ablation procedures. I am excited to witness its impact in action and the advancements it brings to our field.”
FDA Clears AI-Powered Ultrasound Software for Cardiac Amyloidosis Detection
November 20th 2024The AI-enabled EchoGo® Amyloidosis software for echocardiography has reportedly demonstrated an 84.5 percent sensitivity rate for diagnosing cardiac amyloidosis in heart failure patients 65 years of age and older.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
Ultrasound Device Garners FDA De Novo Nod for Kidney Stone Clearance
November 14th 2024Emerging research demonstrated that the Stone Clear device, which facilitates post-lithotripsy clearance of kidney stone fragments, led to a 70 percent lower risk of relapse in comparison to observation in a control group.
