The research work was initiated by a French team in the mid 80's. The team was led by Jean Bour, MD who was head of a cardiology, internal medicine and critical care unit of a general hospital. His concern was to develop a non invasive method to measure hemodynamic parameters at rest and during exercise. His studies are based on thoracic electrical bioimpedance concepts, but with an enhanced methodology.
At first the approach was merely clinical and empirical. The group collected an extensive patient database, with widely different physio-pathological and hemodynamic parameters, and varying impedance signal patterns. By using this database, their idea was to categorize signal patterns and find a model based on pure signal morphology analysis, avoiding the need to measure baseline impedance (Z0).
Dr. Bour first patented the system in France in 1993. Validation studies were performed later in the French University Hospitals of Strasbourg, Rennes, and Angers, among others. Manatec Biomedical was incorporated in 1995 and started operations in June 1996. The company started to manufacture and market a first series of devices, called PhysioFlow® PF-03™. These devices derived directly from the last impedance cardiograph prototypes developed by Dr. Bour.
After that experience, we started to market PhysioFlow® PF05 Lab1™ in 1999, with improved new features and user friendliness. The software was entirely redesigned under Windows™ 95/98, and CE marking obtained. Manatec Biomedical is now ISO9001 and ISO13485 certified.
A sister company PhysioFlow® Inc. was incorporated in the USA in 2006 and is now the global headquarters for the entire business. The group entered a strategic partnership with Vasocom Inc. (now Neumedx Inc.) in order to market the technologies in North America. US FDA approval was obtained for PhysioFlow® PF05 Lab1™ in April 2008 and the new portable device PhysioFlow® PF07 Enduro™ was launched overseas in December 2010.