Japanese medical device maker OMRON Healthcare has received the US Food and Drug Administration (FDA) De Novo authorisation to market its new blood pressure monitors.
Its IntelliSense AFib machine-learning algorithm automatically analyses the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, which causes stroke.
OMRON Healthcare is offering the AI-powered AFib screening solution as part of its ‘Going for Zero’ initiative aimed at preventing heart attack and stroke.
OMRON Healthcare president and CEO Ranndy Kellogg said: “AFib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that.
“Our new AFib detection feature keeps a closer watch on this high stroke risk condition during routine blood pressure monitoring, making AFib detection more widely accessible and more often practised so we can help reduce the health risk.
“OMRON invested in the De Novo pathway to affirm our commitment to medical-grade accuracy as we work to develop and introduce first-of-their-kind technologies.”
FDA authorised the new AFib detection technology through its De Novo pathway, granted for medical devices with advanced technologies that are not currently available in the market.
OMRON’s IntelliSense AFib algorithm incorporates more than 300 mathematical indices to analyse the Pressure Pulse Wave to detect disturbances specific to AFib with high accuracy.
According to a recently published clinical study, OMRON blood pressure monitors with Intellisense AFib showed 95% sensitivity and 98% specificity for AFib detection.
Kellogg added: “High blood pressure affects more than half of all US adults and is a top AFib risk factor. With this De Novo authorisation, we are making it easy and routine for anyone with an Intellisense AFib-equipped OMRON blood pressure monitor to check for AFib.
“90% of heart attacks and strokes are preventable through regular blood pressure monitoring and behaviour change. Teaching those we serve how to monitor and act for better heart health is what Going for Zero is all about.”
