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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 and improve patient outcomes developed much more recently. The U.S. FDA is striving to support innovation with new programs and guidelines that improve…
Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for accessible resources, including preclinical support, needed to support innovation in care for cardiovascular physicians and their patients. In 1999, his collaboration with other Atlanta area interventional cardiologists and cardiothoracic surgeons resulted in the development…
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…
“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a problem we addressed with enthusiasm and with the support and encouragement of Dr. Emily Blum and Dr. Jenelle Foote.”
“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,…
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…
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…