Talking Good Lab Practices(GLP) with FDA Representatives and Industry Leaders at SQA 2017

The Society of Quality Assurance is dedicated to promoting quality in the regulated research community, including clinical settings, laboratories, and manufacturing facilities. This year the annual meeting, held March 26-31, boasted attendance of over 800. Located in National Harbor, Maryland, the conference was in close proximity to Washington DC, posing a unique opportunity for more…

Meeting the top needs in preclinical studies for orthopedic devices: the first structural, completely porous bioactive glass

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…

Meeting the top needs in preclinical cardiology. Understanding the interaction of next generation bioresorbable platforms with underlying vascular tissue.

How T3 Labs helped Abbott Vascular, Dr. Bill Gogas, Dr. Sandeep Kumar, the core teams of Emory University lead by Dr. Habib Samady, and Georgia Tech lead by Dr. Hanjoong Jo, generate and utilize observations from a very long-term translational study toward the understanding of very late vasomotor responses and gene expression profiles in arteries…

From the back of the napkin through preclinical and commercialization for cardiology interventions

T3 Labs and GCMI always stand ready to help new medical devices and their innovators advance from ‘back of the napkin’ ideas often generated in clinical practice from concept to commercialization and eventually, to cure. Recently T3 Labs’ Deepal Panchal joined Health Connect South Radio Host CW Hall and Dr. Neil Weintraub, MD, Kupperman Eminent…

A Partner That Understands Your Science & Your Product Development Needs

At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA. Our preclinical testing and training program leaders are trained scientists themselves, interested in understanding and participating in the science and methods behind innovations…

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…