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GCMI Design & Development has moved to gcmiatl.org
Top preclinical CROs carry certifications including AAALAC, GLP, USDA registration and Animal Welfare Act compliance. A high value preclinical CRO understands their customers’ science, have significant numbers of biomedical engineers on staff and are prepared to support those sponsors at multiple inflection points on their pathway from concept to commercialization. GCMI’s preclinical testing and bioskills training facilities tick all of those boxes and then some when combined with our Lifecycle Advisory and Design and Development services.
Based on decades of collective experience conducting preclinical studies and writing preclinical final reports, our team details what makes a good preclinical study final report. Read more.
Once it’s “go time,” how do you design an efficient in vivo preclinical testing study? What are the top requirements that give the greatest chances for success? Read more.
Our cardiology / cardiothoracic preclinical testing experience includes interventional, structural heart, electrophysiology, and renal nerve ablation technologies. Our preclinical, GLP work for leading cardiology/cardiothoracic device manufacturers employs a wide variety of techniques and models tailored to the test article. Our GLP and AAALAC accredited preclinical CRO facility includes a real-life cath lab, high quality operating rooms and all of the equipment needed.
Our preclinical CRO team has the surgical, veterinary and specialized experience needed to generate positive preclinical results for your drugs and biologics programs. Delivery, dosage, biodistribution and toxicity are the top challenges for developers of new drugs and biologics. Particularly so, for those specific indications where current therapies are underwhelming. Heart attacks, critical limb ischemia, wound healing, stroke and ALS (amyotrophic lateral sclerosis) are a few of the unmet medical needs that will require new, innovative approaches for better treatments and eventual cures.
Our orthopedic preclinical testing experience includes spine, large joints, and extremities treated with devices, biologics and cell-based products. Models include, but aren’t limited to: Spine fusion, degenerative disc disease, orthopedic infection, tendon repair/replacement, fracture healing and critical-sized defect models. Our GLP and AAALAC accredited preclinical CRO facility includes high quality operating rooms and all of the equipment needed, including Digital x-ray, Micro-CT, MRI and CT, surgical instrumentation and qualified plastic histology labs. Model development is available.
Our general surgical testing experience for preclinical includes gastrointestinal, wound healing and organ transplant to name a few. Our GLP and AAALAC accredited preclinical CRO facility includes high quality operating rooms and all of the equipment needed including ECHO including ICE, TTE and TEE, C-arms and MRI and CT. Model development is available.
Our regenerative medicine testing experience includes products for wound healing, cardiovascular and orthopedic applications. Our GLP and AAALAC accredited preclinical CRO facility includes high quality operating rooms and all of the equipment needed including cell culture and sorting, C-arms, ECHO including ICE, TTE, TEE, Doppler, IVUS, OCT, Micro-CT, MRI and CT.
Our preclinical testing experience in other fields includes dermatology, neurology, and urology. Dermatology models for preclinical include wound healing in normal or diabetic models and air pouch models. Neurology models for preclinical include stroke and traumatic brain injury models. Urology models include for preclinical renal calculi, street urinary incontinence, and embolic delivery models.
Our preclinical facilities are AAALAC accredited, USDA licensed, and GLP compliant. We operate 32,000 sq ft of operating room, lab, office and vivarium space.
“Adopting a protocol that more closely mirrors the actual clinical application in humans, was a high value recommendation brought forth in advance of the in-vivo preclinical work. Working with the great team at T3 Labs has dramatically improved the timeline to test the novel molecules in the clinic, most notably to heart attack patients receiving percutaneous coronary intervention (PCI).”
– Lindon H. Young, Director of the Endocrinology and Introduction to Human Disease and Therapeutics courses in the DO program at the Philadelphia College of Osteopathic Medicine (PCOM)
““Designing and managing the logistic demands of a large animal study is complex and requires much more knowledge than a bench scientist’s,” he said. “That’s where the team at T3 Labs has been exceptional. They fill in all of the translational gaps for our requirements with very high levels of proficiency. The ability to execute cardiac cath lab preclinical programs combined with electrophysiology is exceedingly rare. T3 Labs has the infrastructure and expertise to make it happen.”
– Hee Cheol Cho, PhD, Urowsky-Sahr Scholar in Pediatric Bioengineering, Associate Professor, Departments of Biomedical Engineering and Pediatrics at Emory and Georgia Tech
“A good preclinical partner must be able to adapt to the needs, schedule and budget for a specific project. T3 Labs, now part of GCMI, has been an outstanding partner in supporting ALung throughout many preclinical studies.
“Preclinical work is always filled with unexpected outcomes – some good, some bad. Having a trusted preclinical partner that has the experience, expertise, and flexibility to work with your specific product, team, timeline and budget is of the utmost importance.”
– Jeremy Kimmel, PhD, Vice President of New Technologies for ALung
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Steve Rybka, CEO of Vesalio
“We cannot think of a better Preclinical CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.” – Dr. Tom Barrows, President & Chief Science Officer of Cell Constructs
“At T3 Labs they have the perfect setup for what we needed. From the cath lab to fluoroscopy to large animal proficiency, not to mention years of expertise specific to cardiology. The entire staff is excited and interested in our technology.” – Dr. Rebecca Levit, Chief Scientific Officer of CorAmi Therapeutics
“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, Senior Director of Product Development at St. Jude Medical
“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective; we learned that we needed to engage the right partners to do that.” – Tyler Wanke, Co-Founder and CEO of Innoblative
“The facilities are top tier. We designed the facilities to make it easy to move from concept through protocol to budgeting and now it happens as efficiently as possible.” – Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc.
What’s the current state of preclinical work for advancements in circulatory assist devices? GCMI’s Michael Sweet recently shared his insights.
If you’re evaluating your new cardiothoracic technology’s readiness for preclinical work including pilot studies, evaluating preclinical CROs in general, or if you just want to get together to talk about the latest in preclinical testing, bioskills training or medtech innovation across the board, set up a time to meet up with GCMI and T3 Labs at #AATS2023
If you’re evaluating your new artificial organ technology’s readiness for preclinical work including pilot studies or if you just want to get together to talk about the latest in preclinical testing, bioskills training or medtech innovation across the board, set up a time to meet up with GCMI and T3 Labs at #ASAIO2023
“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 improved the safety and efficacy of scores of new medical technologies.”
GCMI and our preclinical CRO T3 Labs proudly support Georgia Tech BME Capstone projects, including the Fall 2022 effort from Team Wristy Business, taking on an unmet need for scapholunate ligament tears.
What are the preclinical implications for developers of novel cell and gene therapies?
In short, they are a significant departure from the typical preclinical testing requirements to which the manufacturers of these therapies, almost exclusively pharmaceutical companies, are accustomed.
3D printing and bioresorbable material technologies are actively realizing personalized medicine in the clinical setting improving the lives of patients worldwide.
What, then, are the preclinical testing implications for innovators working with, or relying upon, 3D printed or bioresorbable material technologies?
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 and improve patient outcomes developed much more recently.
What is the current state of preclinical testing of new medical technologies, drugs and biologics? GCMI Director of Scientific Affairs shares his perspective and insights.
“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a problem we addressed with enthusiasm and with the support and encouragement of Dr. Emily Blum and Dr. Jenelle Foote especially with regard to patient, user and clinical needs.”
“The personnel at T3 Labs has randomized the treatments (test and control agents) and have implemented rigorous study design protocol (e.g. location of area at risk) to enable clear and concise reproducibility of the in-vivo myocardial infarction model to render valid comparisons between the test and control compounds used in the study protocol,” Lindon wrote. “We have completed testing of the first test agent and the results indicate a robust reduction in infarct size (i.e. 70% reduction) in the test compound vs.the control compound group accompanied with significant improvement in post-MI cardiac function.”
“In our tests supported by GCMI and T3 Labs, we found our device reduces pericardial entry depth by over three times less compared to currently available technologies including the 18 gauge needles on the market.”
“Because of this research collaboration between Georgia Tech, Emory, Children’s and GCMI, one of the biggest problems affecting patient safety in hospital settings might finally be solved.”
The IDE process allows a limited product release to enable the clinical use of a new device. The trial can then study a device’s safety, efficacy, and usability when there are too many unknowns for a general market release. The market release is constrained for use as prescribed in the clinical trial protocol and limited in distribution in approved institutions. All this is intended to mitigate the risk when studying a novel technology. The IDE is a common, critical activity and waypoint in the path to FDA full market approval.
“The more translational we became, the more I understood the lives of the patients who have to live with existing pacemaker technology. “The ability to conduct fundamental and translational studies in small and large animal models in the same location with a highly qualified preclinical staff who understand our needs and our science was the final piece of the puzzle. I distinctly remember flying out of Hartsfield-Jackson that day knowing that this is the place.”
“Mabrouk and Inan worked with Patrick Strane, an engineer at GCMI, to figure out how to prepare the device for human testing. After analyzing the device, they decided to make improvements to its packaging, which made it safer for children and more resilient to stringent hospital cleaning standards.”
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance from GCMI and T3 Labs—to advance development of its needle guidance system.
What is the current state of the preclinical testing landscape in the United States? GCMI Director of Scientific Affairs Evan Goldberg sheds some light on that question in a Q&A with Write2Market’s Paul Snyder.
We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice. Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all preclinical programs and RFPs are not created equal. Read on.
At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA. Let us convince you.
GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services. Our AAALAC accreditation and GLP experience validate these claims. But you don’t have to take our word for it. Read on.
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols. What happens if and when a regulatory body returns questions? We won’t turn your project away because it’s too hard, or because we haven’t done it before. We pride ourselves on our interest in your project and our accountability. Read on including a few words from two of our clients.
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not your surgeons’ sole concern. Read on.
Where does preclinical testing enter the design and development phase of new medical technologies and devices? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg share deep dive insights.
“At the end of the day, some testing requirements in the design and development phase simply cannot be done ‘on the bench,’ Evan says. “In design input requirements and confirmation activities within the design and development phase, only cadaveric or small scale in-vivo testing can determine if a device provides appropriate grip or traction for the user, or if it works as intended in a beating heart or vessels with blood flow. Read on.
“We needed more detail and more evidence on our technology’s potential beyond a porcine heart,” Jackson told us. “We liked what we saw from our early testing, but the access to a cadaveric testing opportunity and support with the GCMI and T3 Labs team was invaluable to our work. With their help, we proved the system can produce the pressure required while inflating at a rate that would not tear the pericardium.” Read more about the Best Interdisciplinary Team in the Fall 2020 Georgia Tech Capstone Design Expo.
Project planning is the beginning of formal product development process, wherein the identified team enters a design control process that complies with medical device regulatory requirements (in the United States, per the FDA) and business strategy. This phase is all about determining the resources, the timing, and the work that’s required for product success.
Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for preclinical work in this early development stage? GCMI Preclinical Program Director Evan Goldberg shares his insights in this Q&A.
Design validation ensures that you have made the “right” product – according to the customer’s needs. Design verification ensures that the team has made the product “right” – according to regulatory and engineering requirements.
How does verification and validation in the design and development process “translate” to preclinical?
Find the insights from GCMI / T3 Labs Preclinical Program Director Evan Goldberg tells us in this Q&A. Read more.
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards for our medtech and life science customers. Read on.
Preclinical studies can be expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but not always obvious. What are the most common cost types you should consider when planning your preclinical study and evaluating a preclinical CRO? Read on.
Quality preclinical research begins with a robust preclinical study protocol. Preclinical study protocols can make or break a study, and are the foundation on which reports required by regulatory bodies are built. Our team of subject matter experts have outlined what to include in a preclinical study protocol. Read on.
Think of your GLP study as a final exam. They follow months, if not years, of “course work.” They can make or break your innovative medical product. Like a tuition bill (including your final exam), GLP studies are costly. Be prepared with everything on our list below, BEFORE you start that study. Click here to read.
How do we get preclinical studies right for our customers? Easy access to resources, flexibility, experienced staff, and attention to detail and timelines are the high points. Read more.
“This was a make-or-break moment for us. Having credentialed professionals managing the study, board certified veterinarians on staff and a team who cared about the project as if it was their own, is a distinguishing feature for GCMI/T3 Labs.” – Tyler Wanke, Co-Founder and CEO, Innoblative
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it…
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GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices…
GCMI’s Spring 2023 Capstone Spotlight on Team LifeSTEM “Gliomas are brain tumors that come in multiple forms ranging from low-grade,…
2023 Capstone Team Phantom Lead: a leadless pacing device that utilizes transcatheter delivery for placement in an unconventional location within…
“X-rays supporting our testing at GCMI and T3 Labs clearly showed where the device engaged and the tip aligned at…
Evaluating your new artificial organ technology’s readiness for preclinical work or just want to get together to talk about the…
The National Center for Biotechnology Information describes mechanical circulatory assist devices as, “commonly used in the treatment of severe heart…
“Founded in 1917, the American Association for Thoracic Surgery (AATS), along with its philanthropic arm, the AATS Foundation, has sought…
Image credit: Clinical Imaging Systems GCMI, the U.S. proving ground for medtech innovation, has recently acquired a GE LightSpeed VCT…
“Because we followed a solid pathway, we had a lot more latitude to make positive changes that should increase the…
Quick Insights Aligned in Acceleration: Indeed, the Most Expensive Preclinical Study is the One You Have to Do Twice As…
Roughly one decade ago, scientists made significant improvements in viral vectors’ ability to deliver genetic therapeutics. Those therapies use genetic…
Life science companies of all shapes and sizes rely on preclinical contract research organizations (CROs) to generate the data and…
As we shared recently, our colleagues at Within3 are using technology to accelerate pharma and medtech innovation in some very…
Our colleagues at Within3 are using technology to accelerate pharma and medtech innovation in some very interesting ways. Their platform…
The phrase “personalized medicine” has been thrown about by so many for so long in healthcare as to defy definition:…
Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022…
Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for…
As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to…
“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a…
How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries. During…
Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval…
Congratulations are in order! GCMI Chief Executive Officer, Sherry Farrugia, and Director for Product Development Mike Fisher, were among those…
Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022. They’re seeking the southeast’s…
Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization…
Meet Georgia Tech BME Fall 2021 Capstone Team Five of Hearts The Unmet Need Heart disease, Viral infections, autoimmune…
“Our confidence in data generated by our in vivo studies with T3 Labs cannot be greater.” – Dr. Hee Cheol…
Preclinical proficiency and Georgia ‘medtech’ ecosystem assets yield data needed for follow-on, translational funding The Problem – When Nature…
If you’re attending ORS 2022 and have a new orthopedic technology in development, including preclinical work that may be on…
New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by…
In 2014, a Children’s Healthcare of Atlanta nurse, Lynn Pogue, approached an engineer, Leanne West from Georgia Tech, to discuss…
Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed…
According to the American Red Cross, every two seconds someone in the United States needs a blood transfusion. That fails…
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more…
Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February…
The Fluid Fighters Capstone team needed to test their prototype for draining rates and tissue adherence or occlusion avoidance. GCMI’s…
Yoel Alperin, Parth Gami, Sindhu Kannappan and Kelly Qiu comprise the Georgia Tech Spring 2021 Capstone Design Team ScolAlign. Their…
“Our validation work would not have been possible without GCMI’s support and T3 Labs’ facility and equipment. Being ‘radio-opaque’ is…
“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in…
We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also…
At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the…
At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers. GCMI is committed…
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing…
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your…
In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically…
There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24…
How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development…
Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for…
Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases…
How does medtech design verification and validation “translate” to preclinical testing? GCMI’s Director of Scientific Affairs explains.
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data…
Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash…
A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use…
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities…
Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies.…
The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not…
All preclinical study estimates are not created equal: they may or may not include line items that can widely influence…
Here are some of the most common cost types you should consider when planning your preclinical study to give your…
As the global COVID-19 pandemic continues to force all of us to find safe paths forward, GCMI continues to remain…
When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone,…
Preclinical work, especially GLP studies, are costly and critical to the product’s successful regulatory submission. Efficiency and quality in preclinical…
Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time…
To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have…
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA –…
WE ARE HERE FOR YOU – Here’s what we are doing during this time to keep business moving forward GCMI…
Based on decades of collective experience conducting preclinical studies and writing preclinical final reports (both GLP and Non-GLP), our team…
In mid-November 2019, six student-led Georgia Tech Capstone teams put their medical device ideas to the test at GCMI. These…
Georgia Tech biomedical engineering students Oscar Gutierrez, Ahmed Alnamos, Nishani Kanthasamy and Sondos Alnamos make up the team ‘Bullseye’ for…
Aprons of Shield set out to design a device that achieves full-body shielding from radiation for clinicians while still giving…
As the year comes to a close and many of us look forward to a holiday respite, I find myself…
Georgia Tech Biomedical Engineering students Robert Bridenhagen, Gabriel Cruz, and Annika Clawson teamed up with Computer Engineering student Matthew Aspinwall…
Leading Lap has redesigned the trocar’s tip to prevent puncturing or injuring organs upon insertion. Georgia Tech biomedical engineering students…
Thanks to GCMI’s Capstone Day, the team was able to use their device in a highly clinical, practical situation. “Being…
Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous,…
Finding a trustworthy CRO for preclinical studies is a top priority for medical product innovators. It is always more cost-effective…
The North American Spine Society (NASS) Annual Meeting is the gathering with arguably the greatest ability to influence the global…
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it…
“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective;…
At GCMI, medtech and medical device innovation are at the core of our efforts including our work within our industry…
In October 2018, GCMI and Rambam Medical Center announced the formation of a partnership to help Israeli medtech innovators commercialize…
Yet another edition of the SEMDA Medtech Conference has come and gone. The 2019 edition saw colleagues from 26 states…
The American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting is the world’s largest orthopedic conference with over 30,000 attendees annually…
The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of…
GCMI’s 2018 year end review and 2019 look ahead Thanks to our staff, customers, sponsors and fellow industry, academic…
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it…
GCMI hosts the fifth cohort of Project Engages Last year, we wrote about the amazing work Georgia Tech Professor Emeritus…
Welcome to the third episode in our series about what it takes to get from an idea to a new…
Your innovative medtech or medical device idea may solve a problem that you face on a regular basis, but that…
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I…
As the leading annual electrophysiology event, HRS will always bring the latest advancements in pacing, ablation and mapping to the…
So you have an idea for a new medical device. Now what? Coming up with a concept for a new…
“It is exceedingly rare for student medtech projects to become companies,” Rains said. “But in a very intentional way, and…
Having attended the annual Heart Rhythm Society Scientific Sessions for the past seven years, we can attest to its industry…
An estimated 10 million Americans suffer from atrial fibrillation (AF). The current medications to treat AF have low success rates…
GCMI-T3 Labs will be exhibiting at the Society of Interventional Radiology annual meeting (Booth 833), which will be held March…
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A new medical device’s or product’s pathway from concept to cure to commercialization is fraught with pitfalls, setbacks and usually…
2017 was a year for the books! Our sponsors continue to receive regulatory approvals maximizing their investment in preclinical research,…
Grants season is coming up again! Let’s face it, preparing and submitting a biomedical research grant application is a tedious…
For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills…
The Cardiovascular Research Foundation’s annual TCT conference serves as the premier cardiovascular event of the year: delivering the latest clinical…
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Connect with GCMI and T3 Labs during the 2017 edition of the Georgia Bio Innovation Summit Bringing a new medical…
Connect with T3 Labs during ACG 2017- Booth #526 The American College of Gastroenterology is a recognized leader in educating…
We wish to extend a huge congratulations to our sponsor ALung Technologies! Just last week, it was announced that ALung…
“Children aren’t little adults, yet we expect our physicians to retrofit adult devices to fit a pediatric patient,” says Sherry…
Through Project ENGAGES, a select group of high school students experience the biomedical community and the full view of the…
With preclinical help from T3 Labs and the support of experts within the Atlanta medtech ecosystem, Dr. Rebecca Levit and…
Connect with GCMI and T3 Labs at GSACS 2017! The Georgia Society of the American College of Surgeons (GSACS)…
Who better to address unmet clinical needs and life-changing improvements to medical devices of all types than clinicians themselves? Piedmont…
The Society of Quality Assurance is dedicated to promoting quality in the regulated research community, including clinical settings, laboratories, and…
The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of…
Connect with T3 Labs at AAOS 2017- Booth #1956 The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the…
Between the collaborative efforts of the robust medical ecosystem in the Southeast, and the sponsors who have helped us tell…
Having a facility like T3 to test novel and breakthrough applications’ ability to save lives is crucial for battling diseases…
For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills…
The Masters of Biomedical Innovation and Development program (BioID program) is a collaborative academic experience in Biomedical technology and a…
The Cardiovascular Research Foundation’s annual TCT conference serves as the premier cardiovascular event of the year: delivering the latest clinical…
The World Stem Cell Summit (WSCS) will convene its 12th annual meeting from December 6-9, 2016 in West Palm Beach,…
T3 Labs will be present at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, which will be held…
The American College of Gastroenterology annual conference serves as the premier gastrointestinal event of the year: delivering the latest clinical…
Transcatheter Cardiovascular Therapeutics (TCT) is the world’s foremost educational meeting specializing in interventional cardiovascular medicine. This year, TCT 2016 will…
According to Markets and Markets Research, the global market for spinal implants and devices will top $15 billion by 2020.…
How T3 Labs helped Abbott Vascular, Dr. Bill Gogas, Dr. Sandeep Kumar, the core teams of Emory University lead by…
The American College of Gastroenterology annual conference serves as the premier gastrointestinal event of the year: delivering the latest clinical…
The European Association for Cardio-Thoracic Surgery (EACTS) is holding their annual meeting from October 1-5 in Barcelona, Spain. T3 Labs…
For more than 14 years, Georgia Bio has presented Georgia’s premier bioscience and medtech conference welcoming more than 600 CEOs,…
T3 Labs and GCMI always stand ready to help new medical devices and their innovators advance from ‘back of the…
Over 2,000 physicians and allied health professionals participate in bioskills training programs at T3 Labs every year. Among them is…
Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to cure to commercialization.…
Late last week, T3 Labs, GCMI, Georgia Tech and Emory announced that GCMI signed a letter of intent to acquire…
We would like to thank Jeremy Kimmel and ALung Technologies for recommending such a wonderful and productive conference: ASAIO 2016.…
T3 Labs Training Program Director Kelley Bennett joined SEMDA Executive Director Jason Rupp and GCMI Executive Director Tiffany Wilson on…
Evaluating the readiness of your artificial heart, ventricular or respiratory assist device for preclinical testing, need valuable feedback from clinicians,…
“DDW is the largest annual gathering of surgeons, hepatologists, and gastroenterologists from around the world. The breadth of content covered…
Over 1,300 of the world’s foremost cardiothoracic surgeons comprise The American Association of Thoracic Surgery. It is the definition of…
If you are an early stage medtech innovator and want to talk about your device’s or product’s path to regulatory…
T3 Labs is committed to excellence in translational research including preclinical cardiovascular research. After all, our program leaders are scientists,…
If you are attending the Wound Healing Society 2016 Annual Meeting in Atlanta, odds are you are less than a…
“I’ve gotten more out of these eight hours than I have in any other training facility.” “This is as close…
Remaining on the forefront of FDA requirements and learning from our peers’ experience is why we invest in the SQA…
“At the conclusion of every program, we depart with a great brand name.”
At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational…
In any medical device training program the stakes are high. The investment in time and money, the relationships with your…
The data driving R&D and commercialization decisions in medtech innovation, like histology, can be underpowered and don’t expound the entire…
ALung recently raised $12 million to support the U.S. regulatory approval process for the Hemolung RAS, the world’s first fully…
At T3 Labs we love to connect with our colleagues at industry leading events year-round. Event engagement not only quenches…
Preclinical testing and training industry leader T3 Labs and imaging and image analysis experts ImageIQ use advanced quantitative imaging to…
A surgeon, a product director and a preclinical study director bump into each other at the Omni Shoreham lobby… Well,…
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in…
ALung Technologies continues to rely on T3 Labs for preclinical research for the Hemolung RAS (Respiratory Assist System) as GLP…
At T3 Labs, we are always eager to meet the collective medtech minds at every conference we attend. What projects…
“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant…
ALung Technologies needed a CRO with great flexibility and responsiveness in order to maximize limited resources and accelerate the timeline…
The past few months at T3 Labs have been immensely productive. Along with our preclinical sponsors we continue to produce…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Atlanta is a hidden gem in the national medical device innovation ecosystem. We recently detailed the top reasons why on…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Surefire Medical achieves FDA 510(k) clearance for direct-to-tumor embolization device Surefire Precision in just 76 days with the help of…
Characterizing nerve response post renal denervation is the most critical aspect of any preclinical renal denervation study. Nerve atrophy, healing…
