The CE has approved HealthWatch’s MasterCaution for use as a medical device intended to condition electrocardiogram (ECG) signals for digital transmission via Bluetooth to smartphones and other devices, offering continuous monitoring and immediate event reporting when needed. The company has previously received CE approval for its digital ECG-sensing textile garment (hWear).
The MasterCaution Device (MCD) can function as an ECG machine, event recorder, long-term Holter monitor, and remote telemetry device — all in a single miniature package. It contains an embedded processor for data acquisition, storage and processing, together with an accelerometer, infra-red sensor, and Bluetooth capability. In addition to continuously monitoring 12-lead ECGs, the MCD reports posture, falls, lack of motion, activity, respiration, and skin temperature vital signs enabling near real-time review at a physician’s office, hospital, clinic or other remote medical service center.
“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,” said Uri Amir, CEO HealthWatch Ltd. “With this CE approval, we can start launching our MasterCaution product in Europe and ease the process of obtaining local regulatory approvals.”
Future versions of the MasterCaution Device will incorporate various other modes of communication including direct WiFi and cellular communications along with HealthWatch’s smart Holter functionality.