Arcos and FDA held a joint panel to discuss device integration safety and effectiveness issues at Smart Monitoring 2014. “Every [Department of Defense] branch today said that closed loop therapy is the future,” said Chris Meador, CEO of Arcos. “Let’s talk about specific steps to make that happen.”
During the panel Chris asked several questions to FDA subject matter experts Suzanne Schwartz, MD, MBA, Linda Ricci, and David Strauss, MD. The questions covered new safety and effectiveness issues and risks related to connecting a urine output monitor to the Burn Navigator, then subsequently connecting the Burn Navigator to an infusion pump. These integrations will enable increased automation of fluid resuscitation for severe burn patients, an active area of research for U.S. Army and civilian researchers. Smart Monitoring conferences meet annually before the U.S. Military Health System Research Symposium to discuss needed technology for the military en-route care system.