Aza Technology’s rapid ammonia monitoring device (AMD) [Photo courtesy of Aza Technology]
Aza Technology has hired Elbit Systems of America’s KMC Systems medical instruments division to get the startup’s rapid blood ammonia detector approved by regulators and ready for manufacturing.
Aza Technology developed the rapid ammonia monitoring device (AMD) with Stanford University and Stanford Hospital to detect hyperammonemia, which can lead to irreversible neurological damage, coma and even death in patients of all ages. Current hyperammonemia testing can take hours, but the new device works within minutes with a drop of blood from an earlobe or finger prick, much like glucometers measure blood sugar.
“Between hospital and/or clinic visits, parents and caregivers are challenged to know ammonia levels and when their level would require immediate attention or action,” Organic Acidemia Association Executive Director Kathy Stagni said in a news release. “The availability of a rapid point-of-care ammonia device, such as the AMD, with the capability of monitoring blood ammonia, will be a game-changer for the patient and the caregivers.”
Merrimack, New Hampshire-based KMC Systems said in the news release that the device has been granted Breakthrough Device designation from the FDA for point-of-care measurement of ammonia for use in pediatric patients, including newborns. KMC will help Aza Technology seek FDA approval for use in adult and pediatric patients. KMC will also manufacture the device and its consumables.
Aza Technology is led by CEO Peter Karkantis, who co-founded the company with Thomas Veltman. Read more about the device and Veltman’s hands-on development in this July 2020 article from Stanford News Service.
“The medical device regulatory and manufacturing expertise that KMC offers is the key factor of why we are excited to be partners in this breakthrough innovation,” Karkantis said in the news release.