We’ve been covering wearable ECG devices since 2014 when Alfred Poor wrote about the Zio XT Service ECG patch monitor. Among other developments in ECG, in 2019 we noted VivaQuant‘s RX-1 Rhythm Express wearable arrhythmia device. More recently I had hands on experience with Biotricity’s Bioheart 48-hour continuous ECG recorder.

Global Instrumentation (GI) is another major player in wearable ECG recorders. GI recently announced that its M5 Wearable ECG Recorder received CE Mark certification. This certification means the M5 successfully meets European Union safety, health, and environmental protection requirements. The FDA already cleared the M5 for sale in the U.S., but now GI can market and sell the ECG recorder in Europe as well.

The M5 Wearable ECG Record is a lightweight, patch-style sensor patients wear on their chest. The M5 is water-resistant and GI claims it’s fine to shower with the M5 on your chest. The device has internal storage sufficient to record and store up to 21 days of 3-channel (lead) ECG data. The M5 can record ECG data continuously for up to 14 days with a fully charged battery. GI designed the M5 to be easy for patients to affix to their chest and to use.

There are now multiple cleared choices for ambulatory ECG recording. This capability supports remote patient monitoring (RPM), telehealth, and care-at-home program development.