We are happy to inform you that Microlife has passed another particularly challenging "special-patient" validation. For years, many companies have tried to pass this validation. However, no-one ever managed to pass this validation entirely, until today!
What has been investigated?
The blood pressure measurement accuracy of the Microlife WatchBP office monitor in subjects with atrial fibrillation.
What type of validation study is done?
A validation study has been according to the latest AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in 35 patients.
What makes this validation so unique?
This is the first study to pass a validation protocol in patients with atrial fibrillation for both systolic and diastolic blood pressure. We already had a validation study in atrial fibrillation showing that the device was accurate for systolic blood pressure1 and a clinical study that showed that the Microlife triplicate measurement (MAM) can be used in clinical practice for patients with AF2.
Why is it possible to pass this validation after so many years and why is Microlife the first company to reach this milestone?
This is because of "Microlife AFIB", that automatically detects atrial fibrillation and applies a modified AF-specific algorithm for blood pressure measurement when atrial fibrillation is detected during the blood pressure measurement.
In other words: To pass this validation a synergy of two unique Microlife algorithms was needed. Firstly, Microlife AFIB to identify a patient with atrial fibrillation and secondly its accurate algorithm for blood pressure measurement.