Dr. Ruey-Kang Chang's medical device company, QT Medical, has entered Phase 2 for development of an ECG device designed for long QT syndrome screening in newborns.
We featured Dr. Chang in our "Faculty Spotlight" in March. In that interview, Dr. Chang said that his device would be "the world's most compact 12-lead ECG system designed for newborn babies." He went on to say that it will probably also be the first ECG system that parents or patients without ECG training can do at home with simple instructions.
It seems others see great potential in the device as well. The National Heart Lung and Blood Institute is funding the project with a budget totaling $1.5 million.
In Phase I, QT Medical succeeded in developing the world's smallest 12-lead ECG machine, and an electrode array specifically designed for newborns. During Phase II, the ECG device will be further developed and prepared to be commercially ready. Phase II will involve testing in a prospective clinical trial of 4000 babies screening for long QT syndrome.
The engineering hub for this project is at UC Irvine. LA BioMed will be the project center for a clinical trial of 4000 babies, along with St. Francis Medical Center, Little Company of Mary in San Pedro and Miller Children’s Hospital of Long Beach as collaborating centers.
Dr. Chang will be working with Dr. Henry Lin who will be the PI at LA Biomed and will be in charge of the study.
Dr. Chang serves as CEO of QT Medical, a company he founded that will commercialize his medical technology inventions. He is a pediatric cardiologist focused on public health issues related to infants and children with heart disease. His research has centered on the prevention of sudden death from silent or undiagnosed heart conditions and he has authored numerous publications on the subject.