LifeWatch has received US Food and Drug Administration (FDA) 510k clearance for its internally-developed LifeWatch mobile cardiac telemetry (MCT) patch, a 1-lead ECG system
The LifeWatch MCT 1-lead patch is the newest addition to LifeWatch's cardiac diagnostic monitoring devices.
This latest clearance, when combined with the recently obtained CE mark, enables LifeWatch to provide patients in many parts of the globe with a new diagnostic monitoring patch alternative, according to the company.
The MCT 1-lead patch monitors heartbeats for adverse cardiac events and LifeWatch has said transmits findings to a clinical service center for immediate follow-up.
Stephan Rietiker, CEO of LifeWatch, 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.”