PGS has developed an innovative low cost infant monitoring technology that is completely wireless and requires no intimate patient contact. The PGS monitor combines a state-of-the-art FDA pre-market approved wireless noninvasive inductive respiration sensor with new photo sensor technology for acquiring heart rate, eliminating wires and electrodes. As medical advances improve, the survival rates of pre-term and low birth weight infants in the U.S. continue to rise along with the need for cost effective monitoring. A phase I feasibility study conducted at Children's National Medical Center, Washington D.C. demonstrated that a viable and stable physiological pulse pressure waveform could reliably be acquired at the umbilicus area of the abdomen on low birth-weight infants in the hospital's NICU. The abdominal area was previously deemed inappropriate for monitoring. We further combined the cardiac sensor with the existing PGS wireless inductive respiration sensor. The clinical data collected in the phase I study demonstrated that the PGS motion artifact rejection performance was superior to the reference pulse oximeter monitor. A phase II study is proposed to refine the PGS monitor design and to validate the event detection and recording features in a variety of care settings. Research activities will focus on 1) technical development, which will employ design guidelines to meet substantial equivalence to existing monitors and 2) clinical study, which is structured to support the clinical requirements for an FDA 510(k) application. These goals will be accomplished through a 9-month hardware and software development phase followed by two clinical studies. The long term goals will be to demonstrate the utility, ease of use and ultimate cost savings benefit to the current monitoring programs utilized in hospitals.
