4 min read
Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities,...
1 min read
The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning facilities in Paris and Atlanta combined with the expertise of our people represent the cornerstone of modern preclinical cardiovascular research, offering unparalleled imaging precision for medical device developers like you.
Imaging Excellence In Preclinical Across Two Continents
Our Paris facility features the Aquilion Prime SP CT scanner by Canon Medical Systems, paired with advanced 3mensio Structural Heart software. This combination delivers: superior cardiovascular imaging resolution, enhanced preoperative planning capabilities, precise postoperative device assessment and comprehensive structural heart analysis advancing preclinical research through technology.
Our Atlanta facility houses the GE LightSpeed VCT 64 Slice CT Scanner with gating capabilities, offering: real-time 3D anatomical imaging, intraoperative scanning capabilities, mobile platform flexibility for procedural work and cost-effective testing protocols.
The integration of these advanced CT systems has revolutionized our preclinical testing capabilities enabling our clients to accelerate development timelines, reduce costs between milestones, enhance safety assessment protocols and improve efficacy validation.
“The ability to execute cardiac cath lab preclinical programs combined with electrophysiology is exceedingly rare. [ Veranex ] has the infrastructure and expertise to make it happen.” - Dr. Hee Cheol Cho, Associate Professor, Emory and Georgia Tech
The aortomitral angulation is being measured with the use of our new Canon computerized tomography (CT) scanner, the Aquilion Prime SP.
Quality Assurance and Regulatory Compliance
Our imaging capabilities support preclinical feasibility studies, GLP and non-GLP, for proof of concept validation and safety assessments in small and large models. These comprehensive services span all therapeutic areas, ensuring thorough evaluation of medical technologies before human trials.
“Immediate access to this technology means the data generated is no longer cost prohibitive to many of our customers and prospects. It can also significantly reduce the number of very expensive days between milestones for medtech innovators once the ball gets rolling.” - Michael Sweet, Director of Preclinical Study Management , Veranex
Veranex is a global industry leader in preclinical testing.
Ready to accelerate your medical device’s path to market through industry leading preclinical work? Connect with our preclinical team to learn how our advanced CT imaging capabilities can support your development goals and accelerate your commercialization pathway. We have supported over 100 regulatory submissions returned with no questions asked. Our experts can guide you through the optimal testing protocol with the right resources to get it right the first time for your specific needs.
3 min read
How to Design an Efficient Preclinical Testing Study
A medical device’s pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant...
5 min read
The Promise of Pulsed Field Ablation and the Critical Role of Preclinical Science in its Advancement
Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and...