Cardiovascular Reserve Index (CVRI) calculator receives a CE Mark approval
We are thrilled to announce that the Cardiovascular Reserve Index (CVRI) calculator has received a CE Marking approval.
CE Marking allows clinical use of CVRI in the European Union (EU) and certain other countries that recognize CE Marking. This milestone should benefit both patients and physician users of our tech in Europe & other CE Mark countries.
CVRI stands for Cardiovascular Reserve Index. It detects hemodynamic changes regardless if the patient is compensated or not. CVRI is multi-vital sign index that results a numeric value of CVRI. It detects the hemodynamic change of an individual from his own defined CVRI baseline or from his previous CVRI measurement.
CVRI detects hemodynamic change even when each of the individual vital signs is within normal range and even during the compensated stage. CVRI is patient specific, it is agnostic (not hints to the underlying diagnosis) but directional (decrease CVRI means hemodynamic compromise, increase CVRI means hemodynamic improvement). It enables repetitive measurement and dynamic monitoring which enable pattern detection. The indication is of detecting a hemodynamic change in low risk populations. This is intended for use in patients who are being monitored, that otherwise appear stable, having neither clinical nor vital sign changes that raise concern. CVRI is an additional capability for apparently stable patients who are being monitored. If either clinical findings or vital signs raise concerns of deterioration, there is neither need nor indication to utilize CVRI.
The CVRI Calculator Complies with the dispositions of the directive 93/42/EEC and is classified as class IIa