Image credit: Clinical Imaging Systems
GCMI, the U.S. proving ground for medtech innovation, has recently acquired a GE LightSpeed VCT 64 Slice CT Scanner with cardiac gating capabilities.
“The ability for these machines to generate 3D images of anatomic structures and organs in a pre-op, post-op or intra-operative scenario, including cardiac and vascular imaging, has improved the safety and efficacy of scores of new medical technologies,” GCMI Director of Scientific Affairs Evan Goldberg said. “Providing immediate on-site access to this technology means our customers can now readily access such capabilities when their preclinical testing protocols require it, and avoid additional costs associated with the same.
“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.’”
The mobile platform can accommodate procedural work in the unit itself, opening the door to intraoperative scanning for neuro device implantation or other CT-guided procedures. Acquisition was made possible by support from Georgia Tech and by burgeoning demand for onsite access to it by Georgia Tech faculty, researchers, industry partners and other GCMI / T3 Labs customers.
GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, safety, and GLP medical device testing for studies in any therapeutic area and in small and large models. Since January 2012, we have archived more than 50 GLP studies for leading medical device manufacturers of which more than 25 products have received regulatory approvals.
In the words of a few of those preclinical customers:
- “Designing and managing the logistic demands of a large animal study is complex and requires much more knowledge than a bench scientist’s,” he said. “That’s where the team at T3 Labs has been exceptional. They fill in all of the translational gaps for our requirements with very high levels of proficiency. The ability to execute cardiac cath lab preclinical programs combined with electrophysiology is exceedingly rare. T3 Labs has the infrastructure and expertise to make it happen.” – Hee Cheol Cho, PhD, Urowsky-Sahr Scholar in Pediatric Bioengineering, Associate Professor, Departments of Biomedical Engineering and Pediatrics at Emory and Georgia Tech
- “A good preclinical partner must be able to adapt to the needs, schedule and budget for a specific project. T3 Labs, now part of GCMI, has been an outstanding partner in supporting ALung throughout many preclinical studies. Preclinical work is always filled with unexpected outcomes – some good, some bad. Having a trusted preclinical partner that has the experience, expertise, and flexibility to work with your specific product, team, timeline and budget is of the utmost importance.” – Jeremy Kimmel, PhD, Vice President of New Technologies for ALung
- “Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans.” – Jason White, Senior Director of Product Development at St. Jude Medical If you are evaluating your readiness for preclinical work for your new medical technology, contact us via the form below.