“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] medical technology would have taken years longer without GCMI’s Phase Zero and Phase One services.” As the winner of the 2021 GCMI Baby Sharq Tank competition for their innovative wearable pediatric stethoscope, the interdisciplinary team of Dr. Hong Yeo,…
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…
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…
Congratulations are in order! GCMI Chief Executive Officer, Sherry Farrugia, and Director for Product Development Mike Fisher, were among those recently awarded the Presidents’ Award of Distinction for Team Science from the Georgia Clinical and Translational Science Alliance (Georgia CTSA). In collaboration with an interdisciplinary research team led by Omer Inan, associate professor in…
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…
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…
“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…
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,…
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…