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…
Our colleagues at Health Connect South are in the final stages of preparing for their 2022 Gathering on September 22nd at the Georgia Aquarium. “Though the Southeast is home to world-class health assets, there is surprisingly little interdisciplinary clarity around areas of focus, impact, needs and capacity within and among our health assets. We…
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…
There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24 percent. Resuscitative efforts and supporting technologies are ineffective, slow, fatiguing, traumatic and expensive. As their Fall 2020 Capstone Project, a group of students from the Georgia Tech Schools of Biomedical, Electrical and Mechanical Engineering…
Last month, Georgia Tech named Raghupathy “Siva” Sivakumar inaugural Interim Chief Commercialization Officer. From Georgia Tech Research Horizons: “Sivakumar will bring together commercialization and technology transfer activities from across campus with a goal of moving more intellectual property out into the marketplace to help expand Georgia Tech’s impact on the world. Attaining that goal…
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions. But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat. How…
Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash unnecessarily. Too many promising medtech innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments. It is possible to know earlier in the…
Medtech and life science innovation is a complex, costly endeavor. How do you know you are on the right regulatory track? What activities need to happen in which order to achieve key milestones efficiently? Preclinical work is expensive and the most expensive study is the one you have to do twice. GCMI helps…
A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…