The Medical Imaging & Technology Alliance (MITA) has voiced its support of H.R. 2009, the “Fostering Innovation in Medical Imaging Act of 2017”—a bill introduced by Congressmen Ryan Costello (R-Pa.) and Scott Peters (D-Calif.).
This bipartisan bill provides medical imaging device manufacturers (along with contrast drug manufacturers) with a clear regulatory pathway to ensure patients have access to advanced medical imaging technologies. Many of these new medical imaging technologies are indicated with previously approved contrast agents, MITA officials say.
This bill builds on the 2017 user-fee agreements and will ultimately allow patients in all communities to access innovations in diagnostic imaging by labeling products with new indications for use. What’s more, H.R. 2009 clarifies the U.S. FDA’s authority to continue to consider and clear new indications for imaging device manufacturers, while providing contrast agent manufacturers with incentives to update contrast agent labels for products that have previously nabbed FDA approval.
By clarifying the process for imaging equipment manufacturers to gain approval for new technologies that utilize formerly approved contrast agents, this bill will spur even more innovation, MITA officials say. This is an opportunity to ensure patient access to new imaging technology and give physicians even more specific information when considering treatment options.
“MITA and its members applaud Congressmen Costello and Peters for their efforts on behalf of patients to clear regulatory hurdles and improve access to advancements in medical imaging that help physicians detect disease earlier when it’s more treatable,” says MITA Executive Director Patrick Hope. “We look forward to working in a bipartisan manner to move this bill forward so the regulatory approval process can keep pace with medical innovation that benefits patients.”