The team’s work to date, from concept to the technology’s current state, had primed it to seize the opportunity presented by the January 2022 Centers for Medicare and Medicaid Services (CMS) announcement of five new remote therapeutic monitoring CPT codes.
“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.”
“Our confidence in data generated by our in vivo studies with T3 Labs cannot be greater.” – Dr. Hee Cheol Cho The Preclinical Challenge Dr. Hee Cheol Cho and his team needed sufficient feasibility data from physiologically appropriate preclinical studies to pursue public funding opportunities to complete their translational research for a life changing…
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…
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…
Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…
Medical product design verification and validation activities (called “Phase 3” and “Phase 4” at GCMI) typically come after a design phase (called “Phase 2” at GCMI). At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this…
In one week, a team of students in a joint biotech medical lab with Georgia Tech and Emory students started making and distributing face shields to help save lives. “The goal is to meet the needs locally to actually supply the Georgia Department of Public Health and when they have enough to actually supply…
From the Delta News Hub: April 2, 2020: Delta Flight Products, the airline’s wholly owned subsidiary, is collaborating with Global Center for Medical Innovation (GCMI), a non-profit affiliate of the Georgia Institute of Technology, to manufacture face shields to protect hospital workers during the COVID-19 pandemic. Using materials and designs provided by GCMI, Delta Flight…
Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The team at GCMI is excited to announce that we will be hosting a series of webinars starting next week. Our first webinar focuses on good laboratory practice (GLP) preclinical…