CHARLOTTESVILLE, Va., December 3, 2012 Medical Predictive Science Corporation (MPSC) announces that it has received a Medical Device License from Health Canada for the Heart Rate Observation System, or HeRO® System. This license allows the device to be marketed and sold in Canada indicated for the prediction of sepsis and improvement in mortality.
MPSC CEO Will King commented, “MPSC is very proud to continue building upon the international acceptance of the HeRO System as a safe and effective medical device for infants in the neonatal intensive care units. Adding to the recently received CE marking, HeRO may now be marketed in the European Union, Canada, and the United States.”
“MPSC looks to continue upon our recent successes with regulatory submissions in additional countries. HeRO is a quality product supported by the evidence from a large clinical trial which clearly demonstrated safety and effectiveness.” noted Ray Schumin, Director of Regulatory Affairs. “We are very pleased for the receipt of this license from Health Canada,” he added.
“MPSC is immediately looking to engage partners or distributors in Canada that want to introduce this life-saving technology into Canadian NICUs. We look to fulfill the requests of potential customers in Canada who have expressed significant interest in the HeRO System and had been eagerly awaiting the availability of HeRO,” remarked Geoff Alms, PhD, Exec. VP of Sales and Marketing.
HeRO is a pioneering monitoring system for premature infants that detects early signs of distress, commonly caused by infection and other potentially life-threatening illnesses. HeRO generates an hourly numeric score that quantifies the prevalence of abnormal patterns in each patient’s heart rate and provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are better founded.
MPSC is an entrepreneurial medical device company that translates ICU research discoveries to the patient’s bedside. The company develops predictive technology that detects imminent, catastrophic illness. MPSC’s HeRO monitor is the first of a line of products to monitor in-hospital patients.