Image credit: Clinical Imaging Systems GCMI, the U.S. proving ground for medtech innovation, has recently acquired a GE LightSpeed VCT 64 Slice CT Scanner with cardiac gating capabilities. “The ability for these machines to generate 3D images of anatomic structures and organs in a pre-op, post-op or intra-operative scenario, including cardiac and vascular imaging, has…
If you’re attending ORS 2023 and have a new orthopedic technology in development, including preclinical work that may be on your product development horizon, you have a wonderful chance to connect with our Director of Scientific Affairs Evan Goldberg onsite. GCMI is the U.S. proving ground for global medical innovation. Our mission is to…
Treatment for SLL tears relies on casts and orthopedic screws to stabilize bones while a surgically repaired or reconstructed ligament heals. I”Because we followed a solid pathway, we had a lot more latitude to make positive changes that should increase the likelihood of clinical utility and positive patient impact for our device.”
Roughly one decade ago, scientists made significant improvements in viral vectors’ ability to deliver genetic therapeutics. Those therapies use genetic material like DNA to manipulate a patients’ own cells. Cellular (cell) therapies transfer cells into the patient whether they are the patients’ own cells or cells derived from another location or donor cells. Because…
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…
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 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.
Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022 “For over 60 years, the Orthopedic Research Society (ORS) has been the leading research society supporting engineers, orthopaedic surgeons, biologists, veterinarians, and clinicians in pursuit of a world without musculoskeletal limitations.” GCMI and…
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…
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…