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, feasibility, and safety and efficacy GLP medical device testing for studies in any therapeutic area and in small and large…
GCMI’s Spring 2023 Capstone Spotlight on Team LifeSTEM “Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign tumors to high-grade, malignant tumors including glioblastomas. Glioblastoma treatment involves surgical resection, chemotherapy, and radiation. However, these tumors are typically incompletely resected, so there is a 90% recurrence rate [for a course of treatment,…
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…
Our colleague Chris Rozell, Professor and Julian T. Hightower Chair,Technical Interest Groups: Bioengineering, Digital Signal Processing at Georgia Tech asked us to share the following career opportunity advancing research and education in neuroscience. We hope this initiative and position will have the opportunity to work closely with GCMI in the future. From Chris: Georgia Tech…
Life science companies of all shapes and sizes rely on preclinical contract research organizations (CROs) to generate the data and reports required to bring their innovations to market. To do this effectively, and in a capital efficient manner, each entity needs to understand what they need from the other, when they need it, why…
The team’s work to date, from concept to the technology’s current state, had primed it to seize the opportunity presented by the January 2022 Centers for Medicare and Medicaid Services (CMS) announcement of five new remote therapeutic monitoring CPT codes.
As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost…
Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or…
Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022. They’re seeking the southeast’s most promising life science innovators across multiple life science categories including biopharma, medtech, diagnostic, digital health and agriculture biotechnology technologies. Along with Southeast Life Sciences, we encourage those seeking early rounds of six figures…
Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success. Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study…