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LifeWatch MCT 1-lead patch gets FDA 510(k) clearance

Healthcare technology and solution firm LifeWatch has received 510(k) clearance from the US Food and Drug Administration (FDA) for its 1-lead ECG system, Mobile Cardiac Telemetry (MCT) patch.

Earlier this month, the company also received CE mark approval for the new cardiac diagnostic monitoring patch.

LifeWatch MCT 1-lead patch holds capability to watch every heartbeat for adverse cardiac events and transmits these real time data to a clinical service center for immediate follow-up.

According to the company, the MCT 1-lead patch technology is an easy to use, discrete and lightweight alternative to traditional recording and transmitting devices.

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."

In this month, the company also partnered with AliveCor to expand the remote patient monitoring services.

Under the deal, AliveCor Mobile ECG will be integrated into LifeWatch’s remote cardiac monitoring service.

LifeWatch is involved in developing advanced digital health systems and wireless remote diagnostic patient monitoring solutions.