The newly approved device from Israel-based HealthWatch conditions ECG signals for digial transmission via Bluetooth to connect to smartphones or other communications devices, the company said.
“This CE approval adds data collection and cloud transmission to our product line offering remote 12-lead ECG monitoring saving critical time if cardiac difficulties arise. With this CE approval, we can start launching our MasterCaution product in Europe and ease the process of obtaining local regulatory approvals,” CEO Uri Amir said in a press release.
The MasterCaution can function as an ECG machine, event recorder, long-term holter monitor and remote telemetry device, HealthWatch said. The device can also record posture, falls, lack of motion, activity, respiration, skin temperature and vital signs, according to the company.
“The CE Mark clearly recognizes the importance of the new emerging technology of continuous cardiac transmission in pursuit of improving personal health vital for the emerging m-health industry,” clinical & regulatory affairs manager Dr. Hila Dagan said in a prepared statement.
The device operates in sync with HealthWatch’s digital ECG-sensing garment, which also has CE Mark approval.