FDA clears CVInsight medical device to monitor cardiovascular health


The US Food and Drug Administration (FDA) has given 510(k) clearance to Intelomed for its CVInsight medical device.

CVInsight processes a pulse wave through proprietary algorithms to measure and display vital information such as functional oxygen saturation of arterial haemoglobin (Sp02) and pulse rate of adult and paediatric patients.    

“We are very excited about the introduction of CVInsight. We believe it will have a meaningful impact on the ability to monitor a patient’s vital signs and cardiovascular health, thereby having an extremely positive effect on the quality of patient care,” said Frank Amoruso, CEO, Intelomed.

Jan Berko, Intelomed’s chief researcher and inventor of CVInsight, said: “CVInsight will provide physicians with a non-invasive tool that gives a critical insight into a patient’s declining cardiovascular stability much earlier than some current medical standards by trending of such values. With this early indication, the clinician may be able to determine what action to take well in advance, rather than reacting to recognition measures after the event has occurred. One major challenge facing trauma surgeons and clinicians is the ability to non-invasively measure the circulatory system’s blood volume adequacy in real-time. I believe this could be a very significant step in patient care, especially in the areas of haemodialysis, cardiology, and trauma.”