New Technologies for Neurosurgery, Urology and Endoscopy Earn Inaugural I3 GCMI Research Awards

“In partnership with Georgia CTSA (Clinical and Translational Science Alliance), the I3 (Imagine, Innovate, and Impact) GCMI Research Awards are intended to spark synergistic interactions among investigators from the Emory School of Medicine (SOM) with Georgia Tech affiliate the Global Center for Medical Innovation (GCMI). Proposals are envisioned to improve patient care by more effectively…

When Stars Align – Stridelink quickens its march to commercialization aligned with new remote monitoring capabilities and CMS CPT codes

Occasionally, even in the medtech innovation industry, stars align for a new technology to quickly, powerfully achieve commercialization and the associated clinical outcomes intended.   Such may well be the case for the team and technology at StrideLink.   As we reported last year, “StrideLink is a new technology venture, a first of its kind…

Early, consistent focus on the unmet need keeps Augment Health on a solid commercialization pathway

Stephen Kalinsky and Jared Meyers met on their first day as students in the Department of Biomedical Engineering at Georgia Tech. Five years later, the graduates have completed a 3-month tenure at ZeroTo510 in Memphis and are currently midstream in their endeavor to advance health and dignity for people dealing with spinal injuries or neurological…

The 2022 State of Medtech Design and Development Landscape

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

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

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…

A Scalable, Customized Solution to an Unmet Clinical Need Long in Need of Innovation

How GCMI supported Georgia Tech Spring 2022 Capstone Team UCOLLECT’s Need for Verification Testing on the pathway to commercialization.   “More than 6 in every 10 women will, at some point in their life, be unable to toilet. For these women, the best options include the Foley catheter, a device that is inserted up the…

Phase Zero and Phase One Services Accelerating Wearable Pediatric Stethoscope Path to Commercialization

“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,…

Recording & Insights: An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE)

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…

GCMI’s Sherry Farrugia and Mike Fisher share in the Presidents’ Award of Distinction from CTSA for translational research

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…