ALung raises $12M for its U.S. regulatory path. Congratulations!
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.
The pulse of orthopaedic innovation and preclinical: let’s connect at AAOS and ORS 2016.
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…
Q: Can advanced medical imaging like microCT accelerate preclinical trials? A: Yes.
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…
CRT 2016 Collisions – Good Ones
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…
Preclinical Trials Generate Critical Improvements to St. Jude Medical’s CardioMEMS HF System
“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.
Hemolung RAS Nearer FDA Approval Through Preclinical Research at T3 Labs
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…
Preclinical Case Study: St. Jude Medical & T3 Labs for CardioMEMS HF System
“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:…
Case Study: Selecting a New Preclinical Trials Partner – T3 Labs & ALung’s Hemolung RAS in a Calf Model
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…
The Latest In Preclinical: T3 Labs’ Q4 2015 Quarterly Snapshot
The past few months at T3 Labs have been immensely productive. Along with our preclinical sponsors we continue to produce ground-breaking data. Our sponsors continue to receive regulatory approvals maximizing their investment in preclinical. And our medical device training program continues to ensure physicians and surgeons develop the skills required to fully realize the value…
Top Factors Enabling Swift GLP Turnaround Under Tight Preclinical Timelines
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?