For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available. Once Bio2 Technologies reached the second stage in the process from concept to cure to commercialization – preclinical – they entrusted T3 Labs to deliver three consecutive studies for the first completely…
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…
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…
“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…
Surefire Medical achieves FDA 510(k) clearance for direct-to-tumor embolization device Surefire Precision in just 76 days with the help of T3 Labs.