We develop high quality medical device-grade clinical decision support software. CIMVA software interfaces with standard-of-care monitoring devices in ICUs and emergency departments, therefore integrating into hospital workflows and patient vital sign data harvest, transfer and storage. Our software development process is implemented within a Quality Management System that meets the exacting requirements under FDA 21 CFR Part 820. We do not develop medical device hardware.
Our initial software product – the CIMVA Universal™ platform – is the first FDA approved application to calculate changes in physiological waveform variability across multiple-organ systems or multi-parameters within a single organ system. The CIMVA Universal platform application is the foundation for future FDA approved clinical applications of CIMVA technology developed for specified clinical requirements. Regulatory approval is Canada & Europe is pending.
The underpinnings of CIMVA technology utilizing complex systems theory are the subject of both issued and pending U.S., Canadian & international patents.