American Gastroenterological Association Launches Device Registry Initiative
Bethesda, MD – The American Gastroenterological Association (AGA) Center for GI Innovation and Technology announced today the launch of an initiative to develop observational research registries to help bring new medical devices to gastroenterologists and their patients. The first registry will be announced in March 2014.
The AGA recognizes the potential of new technologies, procedures, pharmaceuticals and diagnostics to improve care for patients with digestive diseases. As a neutral, objective broker, AGA will establish registries to help companies gather the data needed by payers, purchasers, risk-bearing organization and regulatory agencies to support the approval, coverage, reimbursement and adoption of new technologies, therapies and procedures.
“It can take seven to 10 years from device inception to FDA approval, and then an additional two to four years or more before payers provide coverage. That’s too long for patients to wait for innovations that could change lives,” said Pankaj Jay Pasricha, MD, Chair of the Center for GI Innovation and Technology and Professor of Medicine and Director of the Johns Hopkins Center for Neurogastroenterology, The Johns Hopkins University School of Medicine and Professor of Innovation Management at Carey Business School at Johns Hopkins. “AGA wants to speed up those timelines, while encouraging the collection of important data that demonstrates safety, efficacy and ultimately improved outcomes.”
Registries can provide data to allow stakeholders to evaluate the efficacy of a device and document safety and durability. Strict methodology and structures must be applied to an observational registry to balance the needs of healthcare professionals, companies, payers, purchasers, regulatory agencies, the AGA, and patients.
“Over the last decade, several technologies that could have improved gastroenterology care failed due to lack of guidance and support. The AGA offers a unique blend of clinical, research, regulatory and payment knowledge to companies that are working on GI, nutrition, and hepatology devices, therapeutics, and diagnostics,” said Michael L. Kochman, MD, chair-elect of the AGA Center for GI Innovation and Technology and Wilmott Family Professor of Medicine and Vice-Chair of Medicine for Clinical Services at the Hospital of the University of Pennsylvania. “We’re looking to the future and want to ensure gastroenterologists have innovative tools to care for their patients.”
The AGA Center for GI Innovation and Technology does not endorse any product or service, develop guidelines, nor make any guarantees about FDA approval or coverage from public or private payers.
More information on this program is available online.
About the AGA
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.
The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process.