In any medical device training program the stakes are high. The investment in time and money, the relationships with your physicians and the overarching reputation of your company’s brand are all on the line. Founded in 1987 and headquartered in Orange County, California, Applied Medical is a rapidly growing, global organization with over 3,000 team…
The data driving R&D and commercialization decisions in medtech innovation, like histology, can be underpowered and don’t expound the entire product efficacy story. The processing of those images and the associated analysis can be painfully slow and in many cases subject to detrimental observer-based bias and variability – a simple issue of the human eye…
ALung recently raised $12 million to support the U.S. regulatory approval process for the Hemolung RAS, the world’s first fully integrated respiratory dialysis system.
At T3 Labs we love to connect with our colleagues at industry leading events year-round. Event engagement not only quenches our thirst for new scientific knowledge to the benefit of our organization, our sponsors and our team members, it also fosters what’s next for our organization. Because preclinical orthopaedic device testing and training is an…
Preclinical testing and training industry leader T3 Labs and imaging and image analysis experts ImageIQ use advanced quantitative imaging to accelerate preclinical research for medical device and pharmaceutical innovators, bring welcome evolution to regulatory processes and data quality. The challenge – speeding up the medtech development cycle Medical device and biologic innovators, especially in the…
A surgeon, a product director and a preclinical study director bump into each other at the Omni Shoreham lobby… Well, not exactly, but that’s the way the annual CRT conference feels. Like a well designed meeting hub, the event generates “productive collisions” that foster innovation and learning throughout the cardiovascular research technologies ecosystem. Why we…
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans.” Jason White, St. Jude Medical senior director of product development.
ALung Technologies continues to rely on T3 Labs for preclinical research for the Hemolung RAS (Respiratory Assist System) as GLP study for FDA IDE application draws near. ALung’s relationship with T3 began in 2013 for preclinical studies supporting U.S. regulatory approval for the first fully-integrated respiratory dialysis system, Hemolung RAS. Early in the engagement, T3…
“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant improvements before first clinical use. T3 Labs provides extensive expertise and capabilities in the critical preclinical stage of medical device product development.” – Jason White, Senior Director of Product Development, St. Jude Medical The challenge:…
ALung Technologies needed a CRO with great flexibility and responsiveness in order to maximize limited resources and accelerate the timeline associated with preclinical trials. “T3’s recommendation has accelerated our product refinement testing and preclinical trials saving ALung time and money at every step along the way.” – Jeremy Kimmel, PhD Director of New Technology for ALung Technologies…