Interview with Dr. Dov Rubin, Senior VP Marketing and Business Development at HealthWatch
The company has produced the first ECG-sensing textile garment that is a true, clinically tested, FDA-cleared medical device.
HealthWatch’s MasterCaution Device clears the FDA hurdle
The agency cleared it as a Class II medical device intended to condition electrocardiogram (ECG) signals for digital transmission via Bluetooth.
HealthWatch’s MasterCaution Device gets CE approval
The device can function as an ECG machine, event recorder, long-term Holter monitor, and remote telemetry device -- all in a single miniature package.