EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices
As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark...
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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.
GE LightSpeed VCT 64 Slice CT Scanner with cardiac gating capabilities at Atlanta lab
Strategic Imaging Excellence 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
- Comprehensive structural heart analysis
Meanwhile, our Atlanta facility houses the GE LightSpeed VCT 64 Slice CT Scanner with cardiac gating capabilities, offering:
- Real-time 3D anatomical imaging
- Intraoperative scanning capabilities
- Mobile platform flexibility for procedural work
- Cost-effective testing protocols
Advancing Preclinical Research Through Technology
The integration of these advanced CT systems has revolutionized our preclinical testing capabilities:
- Accelerated development timelines
- Reduced costs between milestones
- Enhanced safety assessment protocols
- Improved 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.”
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:
- Feasibility studies
- Proof of concept validation
- Safety assessments
- GLP medical device testing
- Small and large model studies
These comprehensive services span all therapeutic areas, ensuring thorough evaluation of medical technologies before human trials.
“This kind of 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.”
Take the Next Step in Medical Device Development
Ready to accelerate your medical device’s path to market? Connect with our preclinical team to learn how our advanced CT imaging capabilities can support your development goals. Our experts will guide you through the optimal testing protocol for your specific needs.
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