When clinical relevance calls for on-the-fly preclinical protocol deviation

How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries.    During events such as myocardial infarction (heart attack) and surgical procedures involving angioplasty, bypass surgery, or heart transplantation, reactive oxygen species (ROS) can be generated, which cause organ and blood vessel damage. ROS is generated from…

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…

A Safer Way to Conduct Pericardiocentesis – A Procedure Begging for a Technology to Reduce Mortality

Meet Georgia Tech BME Fall 2021 Capstone Team Five of Hearts   The Unmet Need Heart disease, Viral infections, autoimmune diseases, and cancer can all cause excess fluid to fill the pericardial sac. Physicians frequently perform “pericardiocentesis” by inserting a large 18-gauge needle through the patient’s chest and into the pericardial space to drain this…

What high value preclinical support looks like when re-expressing pacemaking cells for cardiac arrhythmia in pediatrics

“Our confidence in data generated by our in vivo studies with T3 Labs cannot be greater.” – Dr. Hee Cheol Cho   The Preclinical Challenge Dr. Hee Cheol Cho and his team needed sufficient feasibility data from physiologically appropriate preclinical studies to pursue public funding opportunities to complete their translational research for a life changing…

Spotlight: Regenerating Pacemaking Cells for Treatment of Cardiac Arrhythmias with Dr. Hee Cheol Cho

Preclinical proficiency and Georgia ‘medtech’ ecosystem assets yield data needed for follow-on, translational funding   The Problem – When Nature Doesn’t Give Us the ‘Pacemaking’ Cells We Need at Birth   Sometimes nature does not provide enough of the human heart’s own, rare and precious, ‘pacemaking cells’. When this occurs, at any stage of life,…

Heading to ORS 2022? Meet with GCMI’s Director of Scientific Affairs Evan Goldberg onsite for end-to-end product development insights including preclinical

If you’re attending ORS 2022 and have a new orthopedic technology in development, including preclinical work that may be on your product development horizon, you have a wonderful chance to connect with our Director of Scientific Affairs Evan Goldberg onsite.   GCMI and our preclinical arm T3 Labs has substantial experience in preclinical work for…

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…

Georgia Tech researchers partner with GCMI to move their innovative IV Sensor closer to clinical trials

In 2014, a Children’s Healthcare of Atlanta nurse, Lynn Pogue, approached an engineer, Leanne West from Georgia Tech, to discuss the burden of IV monitoring. This is when Sherry Farrugia, the current Chief Executive Officer of GCMI, stepped in to help assemble the team that would begin the investigation into a new device capable of…

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…