HealthWatch MasterCaution Device Receives FDA Clearance for 12-Lead ECG and Vital Sign Telemonitoring

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First continuous real-time monitoring of ischemia using hWear ECG-sensing textile garments now a reality.

Monitoring ischemia continuously and remotely.

HealthWatch’s MasterCaution® Device has received FDA clearance as a Class II 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. The HealthWatch smart digital, ECG-sensing textile garment (hWear™) has previous FDA Class II registration.

The MasterCaution Device (MCD) is a miniature device that 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 up to 12-lead ECGs, the MCD reports posture, activity, respiration, and skin temperature enabling near real-time review at a physician's office, hospital, clinic or other remote medical service center.

“The FDA’s 510(k) is another important step in harnessing consumer technology for clinical use in medicine. We are excited about this milestone and look forward to providing this technology to help physicians manage their patients in an effective and efficient way,” said Uri Amir, CEO HealthWatch Ltd.

“This makes next-generation cardiac telemonitoring accessible to the cardiology community. To date, only arrhythmia and heart rate have been monitored remotely on a semi-regular basis. The technology path is now available to also remotely monitor ischemia offering full 12-lead ECG resolution of the heart at any moment in time,” said Prof. David Hasdai MD, Director of the Coronary Care Unit at Rabin Medical Center and Medical Director of HealthWatch Ltd.

HealthWatch anticipates offering future versions of the MasterCaution Device incorporating 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.

About HealthWatch Ltd.
HealthWatch is a high tech-xtile medical device company dedicated to securing personal health through comfortable, smart digital textile garments providing the highest quality ECG, vital signs, and medical alerts for telemonitoring.

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Dr. Dov Rubin
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