HealthWatch’s MasterCaution Device (MCD) has received FDA clearance as a Class II medical device intended to condition electrocardiogram (ECG) signals for digital transmission via Bluetooth to smartphones and other devices.

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. It offers continuous monitoring of up to 12-lead ECGs, as well as 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 of HealthWatch.

Going forward, HealthWatch will update the MasterCaution Device to incorporate various other modes of communication including direct WiFi and cellular communications, along with HealthWatch’s Smart Holter functionality. The company’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 app with no lifestyle change wherever a person may be.