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

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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

Accelerator, Blog, Cardiology & Cardiothoracic, Design & Development, Events, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, 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…

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

Blog, Cardiology & Cardiothoracic, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Preclinical CRO Excellence, T3

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

Blog, Cardiology & Cardiothoracic, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Preclinical CRO Excellence, Regenerative Medicine, T3, Uncategorized

“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

Blog, Cardiology & Cardiothoracic, GCMI, News, Physician Innovators, Preclinical CRO Excellence, T3

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,…

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

Blog, Cardiology & Cardiothoracic, Design & Development, Digital Health, GCMI, GI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Webinar

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

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, T3

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

Bio-skills and medical device training, Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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…

GCMI Capstone Support Spotlight: The Hemogoblins: Extending the Shelf Life of Cold Stored Whole Blood

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Preclinical CRO Excellence

According to the American Red Cross, every two seconds someone in the United States needs a blood transfusion. That fails to take into account injuries sustained by troops in war zones or others needing the precious resource in corners of the world that can take days or weeks to reach.   Yet currently, whole blood…

Faculty Researchers and Innovators: Medtech Innovation does not work like any other form of innovation. What you need to know about IRBs and the medtech innovation process; a GCMI webinar.

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Join us as we walk through the required steps of medtech innovation and, more importantly, why they’re required for academic researchers and innovators with ideas or technologies that could improve healthcare provision, save or improve lives.