LifeWatch (SWX:LIFE) said yesterday that it won 510(k) clearance from the FDA for its mobile cardiac telemetry patch, a 1-lead electrocardiograph system.
Zug, Switzerland-based LifeWatch said the MCT 1-lead patch is capable of “watching every heartbeat for adverse cardiac events and transmitting significant findings, in near-real time, to a clinical service center.”
“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,” CEO Dr. Stephan Rietiker said in prepared remarks.
Back in December 2012, LifeWatch won CE Mark approval for its LifeWatch V health smartphone platform in the European Union.
The post FDA clears LifeWatch patch for remote cardiac monitoring patch appeared first on MassDevice.
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