Reducing the 90% Recurrence Rate for Glioblastoma Treatment Through an Implantable Device for the Delivery of Stem Cells

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,…

Aligned Career Opportunity: Project Manager to Advance Research and Education in Neuroscience.

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…

Stars Align – Stridelink quickens march to commercialization with remote monitoring capabilities, CMS CPT codes

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.

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical Ecosystem

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…

Recording & Insights: An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE)

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…

Are you a life science innovator seeking funding in the next 12 months? Applications are open for PitchRounds at AdvanSE 2022.

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…

An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE): A GCMI Webinar

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…

Faculty Researchers and Innovators: What you need to know about IRBs and the medtech innovation process – Insights & Recording

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…

Demand, Logistics, Technologies and Lifecycle Services: The State of Bioskills Training and Education

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…

The State of Preclinical Studies: A Q&A with GCMI’s Director of Scientific Affairs Evan Goldberg

Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…