LifeWatch AG, a developer and provider of medical solutions and remote diagnostic monitoring services to the digital health market, announced today that it has received U.S. 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 offering, and continues to build on LifeWatch’s commitment to becoming a truly global provider of remote diagnostic monitoring devices and services.
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.
“I am very excited about this milestone which will now allow us to introduce our patch technology to a broader market,” says Dr. Stephan Rietiker, CEO of LifeWatch. “The FDA clearance represents yet another significant achievement for LifeWatch and further strengthens our position as an innovational leader in digital health.”