Medical Device News Magazine

TechsoMed Announces Completion of Full Enrollment in Pivotal U.S trial Evaluating its BioTraceIO Software for Liver Ablation Outcomes Assessment in Liver Cancer Patients

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

TechsoMed, the developer of first of its kind AI Algorithm powered tissue viability imaging technology, announced today it has successfully completed patient enrollment in U.S. Pivotal trial designed to demonstrate the safety and effectiveness of its flagship product, BioTraceIO, in providing valuable visualization and quantitative insights on procedure outcome in liver cancer patients undergoing ultrasound guided percutaneous ablation procedures.

With its algorithm powered technology, the BioTraceIO software system is the first to provide visualization of the ablated area based on standard real-time ultrasound imaging intended to support interventional radiologists performing tumor ablation with valuable procedure outcomes assessment.

Dr. Sadeer Alzubaidi, an interventional radiologist from Mayo Clinic Arizona, principal investigator at the trial said….

“Intraprocedural limited visibility of the area being treated is a true challenge we are facing when performing percutaneous ablation procedures. I believe this hinders the adoption of thermal ablation for treating liver tumors, and I am pleased that new technologies are addressing this challenge. The BioTraceIO enables us, the interventional radiologists, to utilize a standard ultrasound for an added layer of accurate visual and quantitative information of the ablation process. This, no doubt, can increase accuracy and contribute to better care for our patients”.

Dr. Nami Azar, Professor of radiology and principal investigator at University Hospitals Cleveland Medical Center added,

“Ultrasound imaging is critical imaging modality in providing real-time insights during ablation procedures. I am happy to participate in this study to introduce innovative ultrasound monitoring capabilities to the field of tumor ablation. The BioTraceIO solution has the potential to help to see more during the ablation process and to achieve improved procedure outcomes”.

The pivotal trial primarily intended to demonstrate that the BioTraceIO Ablation Map generated based on ultrasound imaging during the procedure is effective at estimating the ablation zone as measured 24-hours post-procedure by CT scan, representing the true ablation area. The trial has enrolled 50 patients across 6 leading clinical sites in the U.S. including Mayo Clinic in Arizona and Minnesota, Stanford, Mass General Hospital, UH Cleveland and Houston Methodist Hospital.

“The completion of our first BioTraceIO pivotal trial is a great accomplishment that reflects a milestone in executing our vision of transforming Thermal Ablation from guess-work into precise, real-time feedback dependent treatment”, said Yossi Abu, TechsoMed’s CEO. “The collaboration with such leading medical centers and physicians indicates the deep recognition of the interventional-radiology community in BioTrcaeIO potential to provide a much-needed clinical value in the liver ablation space”.

Upon the study completion, TechsoMed plans to expand its clinical validation program in the U.S to validate its extended end-to-end BioTraceIO360 software solution designed to equip interventional radiologists with advanced patient-specific procedure modeling, planning capabilities and 3D post-procedure assessment.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.