Global Instrumentation Gains CE Mark for ECG Recorder
Manlius, N.Y.-based Global Instrumentation has received a CE mark certification for its M5 wearable electrocardiogram (ECG) recorder.
The M5 device is designed to deliver precise long-term ECG data in the patient’s home or while outdoors for use by research organizations and physicians.
The recorder, which weighs just 26 grams (0.9 ounces), can store up to 21 days of three-channel ECG recordings. It can be worn with a patch electrode or standard electrodes with lightweight cables.
The company received 510(k) clearance for the device from the FDA in January.