LifeWatch has received another 510k clearance from the FDA, this time for its internally-developed LifeWatch Mobile Cardiac Telemetry (MCT) Patch, a 1-lead ECG system. Said device has already received the CE Mark and is joining the company’s cardiac diagnostic monitoring offering.
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 for immediate follow-up. The product is easy to use, discrete and lightweight, providing an alternative to traditional recording and transmitting devices. Also, it is more comfortable for the patient and should therefore lead to an increase in the diagnostic yield as a result of improved patient compliance.
“I am very excited about this milestone which will now allow us to introduce our patch technology to a broader market,” Dr. Stephan Rietiker, CEO of LifeWatch, said in a statement. “The FDA clearance represents yet another significant achievement for LifeWatch and further strengthens our position as an innovational leader in digital health.”
In a separate news, LifeWatch announced that it will suspend its current home sleep testing services while it “explores new innovations and options for providing a more efficient service to its customers and patients.” The company has taken steps to ensure that customers continue to have a provider for home sleep testing and will be informing customers accordingly.