CE Approves HealthWatch Device for Remote Real-time Medical ECG and Vital Sign Monitoring

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MasterCaution Device makes continuous telemonitoring accessible to all via smart digital, ECG-sensing textile garments

The CE has approved the HealthWatch MasterCaution® Device as a medical device intended to condition electrocardiogram (ECG) signals for digital transmission via Bluetooth technology to smartphones and other remotely located communication devices offering continuous monitoring and immediate event reporting when needed. HealthWatch’s digital ECG-sensing textile garment (hWear™) has previously received CE approval.

The MasterCaution Device (MCD) is a multi-purpose ECG device that 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, data storage, data 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.

“The CE Mark (number 632684) 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,” said Dr. Hila Dagan, Clinical & Regulatory Affairs Manager at HealthWatch.

“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. HealthWatch’s hWear garment -- the digital, heart-sensing t-shirt incorporating interwoven textile electrodes – detects true 3-to-15 lead ECG signals at rest and in motion. These garments enable continuous ECG telemonitoring via smartphone applications with no lifestyle change wherever a person may be. The garments measure the highest quality vital signs all without electrodes or shaving preparations in both men and women and are machine washable.

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Dr. Dov Rubin
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