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…
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…
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…
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…
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.
Georgia Tech’s impact on the state’s economy totaled $4 billion in the fiscal year 2020 according to data released by the University System of Georgia. GCMI was honored to be mentioned as one of the organizations that contributed to this remarkable number.
A team of mechanical, electrical and computing engineers, supported by the Director of Cardiac Intensive Care for Children’s Healthcare of Atlanta, has been named winner of the inaugural GCMI Baby SharQ Tank Pitch Competition for their novel, low cost, wearable pediatric stethoscope. The interdisciplinary team, including engineers (Dr. Hong Yeo, Dr. Yun-Soung Kim, and…
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance…
Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…
How we walk is a key indicator of any injury, recovery pathway and overall health. Clinicians’ analysis for assessment of gait is still done in a highly subjective way with the naked eye. As such, physical therapists struggle to track patients’ recovery and therapeutic process without a technical, objective yet visual solution for gait assessment.…