Who brings what to the table? Artivion’s Deepal Stevenson, M.S. shares her insights on the client / CRO relationship for effective, efficient preclinical studies and reports.

Blog, Cardiology & Cardiothoracic, GCMI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

Life science companies of all shapes and sizes rely on preclinical contract research organizations (CROs) to generate the data and reports required to bring their innovations to market.   To do this effectively, and in a capital efficient manner, each entity needs to understand what they need from the other, when they need it, why…

Preclinical Implications for 3D Printed and Bioresorbable Medical Technologies

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, News, orthopedic, Pediatric, Physician Innovators, Preclinical CRO Excellence, spine, T3

The phrase “personalized medicine” has been thrown about by so many for so long in healthcare as to defy definition: or require post graduate work in any one of dozens of specific clinical or technological fields.   For the sake of brevity, 3D printing and bioresorbable material technologies are actively realizing personalized medicine in the…

The 2022 State of Medtech Design and Development Landscape

Accelerator, Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, News, Physician Innovators

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…

Rooted in Cardiology: Let’s talk preclinical and cardio innovation at TCT 2022

Blog, Cardiology & Cardiothoracic, Conferences, Design & Development, Event, Events, GCMI, News, Physician Innovators, Preclinical CRO Excellence, T3

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…

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

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

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…

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

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

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)

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Webinar

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.

Accelerator, Blog, Cardiology & Cardiothoracic, Conferences, Design & Development, Digital Health, Events, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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…

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,…