The US Food and Drug Administration (FDA) has granted 510k clearance for Switzerland-based LifeWatch‘s Mobile Cardiac Telemetry (MCT) Patch, a 1-lead ECG system.
The MCT 1-Lead Patch is the newest addition to the company’s cardiac diagnostic monitoring offering, and builds on its commitment to becoming a truly global provider of remote diagnostic monitoring devices and services.
Combined with the recently obtained CE Mark, the FDA clearance allows the company to provide patients worldwide with a new diagnostic monitoring patch alternative.
The patch is capable of monitoring every heartbeat for adverse cardiac events and transmitting significant findings in near real-time to a clinical service centre for immediate follow-up.
Compared with traditional recording and transmitting devices, the MCT 1-Lead Patch technology is an easy-to-use, discrete and lightweight alternative.
The technology is significantly more comfortable for the patient, so should lead to an increase in the diagnostic yield as a result of improved patient compliance.
LifeWatch CEO Dr Stephan Rietiker said: "I am very excited about this milestone, which will now allow us to introduce our patch technology to a broader market.
"The FDA clearance represents yet another significant achievement for LifeWatch and further strengthens our position as an innovational leader in digital health."
LifeWatch specialises in advanced digital health systems and wireless remote diagnostic patient monitoring services.
The company’s services provide physicians with critical information to determine appropriate treatment and thereby improve patient outcomes.