Every time I visit my primary care physician’s office, they start by taking my weight and blood pressure (both of which are higher than I’d like). I use an Omron upper arm cuff device at home to measure my blood pressure periodically, following the AHA’s updated regimens.
The single reading at my PCP’s office is almost always higher than the range of measurements I observe at home. When I comment on the BP numbers, the reply is often, “But it’s in a doctor’s office.” The implication is that office readings are neither valid nor reliable. The AHA report implied the same concern with in-office blood pressure readings. If ambulatory at-home blood pressure readings are more relevant for hypertensives, it follows that for many of the same reasons ambulatory ECGs would be more helpful for detecting signs of cardiac disease than ECGs in a clinical setting. Valid in-home ECGs are not as easy as blood pressure measurements, however.
VivaQuant‘s RX-1 Rhythm Express wearable arrhythmia device relies on algorithms and patented signal processing technology to overcome many of the issues with variable ECG readings. Traditional ambulatory ECGs are subject to errors, false positives, and other problems because of muscle noise, baseline wander, movement artifact, and in-band noise. VivaQuant’s proprietary MultiDomain Signal Processing (MDSP) technology reduces in-band noise in ambulatory ECGs by the equivalent of 95%. The more significant point is the MDSP noise reduction occurs without distorting the ECG Signal.
Due to the RX-1’s ability to “accurately and efficiently identify and report cardiac arrhythmias,” the FDA recently gave VivaQuant 510(k) clearance for the wearable. The RX-1 can serve multiple roles as a mobile cardiac telemetry device, event recorder, or Holter monitor. The device itself is a small, one-piece device that can be worn in the shower.
The smartphone-size RX-1 is a 4-lead ECG that captures 2-channel data. The wearable runs on battery power for up to 14 days of continuous monitoring before it needs recharging. Event buttons on the device let patients characterize events immediately and easily. Data is sent via wireless cellular networks directly to the monitoring center. The Rhythm Express analytics and machine learning identify AFib/AFL, PVCs, bradycardia, tachycardia, and pauses and report directly to the patient’s clinician.
VivaQuant primarily sells Rhythm Express to clinics and hospitals for cardiac arrhythmia assessment. The company also sells to the pharmaceutical and medical device industries to test the cardiac safety and efficacy of their products.