ArteVu

ArteVu is an automatic, continuous, noninvasive blood pressure monitoring system that uses a disposable finger clip with a tactile sensor to detect pulse pressure waveforms. It derives blood pressure and pulse rate through pulse waveform decomposition analysis, calibrated using a standard upper arm cuff, and displays results on a compatible remote monitor. The device is intended for use by clinicians on adult patients aged 50–86 years at rest in a supine or reclined position in professional healthcare facilities.

ArteVu uses a finger clip with passive electronic components and a tactile sensor to measure pulse waveforms, whereas the predicate CareTaker4 uses an oscillometric cuff on a digit requiring constant coupling pressure. ArteVu's finger clip design minimizes risk of blood flow occlusion during extended use and does not require additional pressure beyond clip placement. Both devices utilize pulse decomposition analysis calibrated to ISO 81060-2 standards and display blood pressure and pulse measurements on a monitor via wired transmission.

ISO 10993 (biocompatibility), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), ISO 81060-2 (blood pressure measurement standards), ISO 81060-3, ISO 80601-2-61, and IEC 60601-2-27 (specific monitoring device standards). The clinical study incorporated elements from IEEE 1708 standards.

ArteVu and CareTaker4 share the same intended use: noninvasive continuous blood pressure and pulse rate measurement using pulse waveform decomposition for resting adult patients. Both employ calibration per ISO 81060-2 and display results on a monitor via wired transmission. Although ArteVu uses a finger clip design whereas CareTaker4 uses a digit cuff, nonclinical testing demonstrates ArteVu meets the same performance benchmarks, and a clinical study of 109 subjects showed comparable safety and effectiveness to CareTaker4, with adverse events unrelated to the device. The technological differences do not raise different safety or effectiveness questions.