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…
New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by regulatory agencies responsible for safety and efficacy. As far as those regulatory bodies are concerned, the path to clinical trials in humans is the same whether it’s research or commercial driven. Failing to walk that…
Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed . Teams leaned on virtual engagement technologies, dedicated lab staff, and proctors onsite, to deliver the training and education required to learn how to safely employ new technologies, products and techniques. At the importance of…