ACS Receives FDA 510K Clearance for new cardiac device that combines resting 12-lead EKG, Holter, and Mobile Cardiac Telemetry (MCT) in one unit
Contact: Christopher S. Kane, Vice President of Marketing
Phone: (800) 423-2929
Fax: (949) 581-1009
Laguna Hills, CA: APPLIED CARDIAC SYSTEMS, Inc. (ACS), a recognized leader of non-invasive instrumentation, is proud to announce that it has received 510K clearance from the Food and Drug Administration for its newest cardiac device, the Core.
The Core is the first and only mobile cardiac telemetry (MCT) device to be approved for applications other than just MCT. The Core has the capacity to stand-alone as a resting 12-lead electrocardiogram (EKG), it can be a separate Holter unit, or it can be used in combination as a long-term MCT monitor. The Core device is invaluable to clinical facilities as it can function as more than just a long-term monitor.
ACS has also received clearance for its revolutionary new embedded ECG arrhythmia and alarm detection program. The Core is the only mobile cardiac monitor on the market to have also received clearance for detecting ventricular flutter and ventricular fibrillation. Not only will the Core capture these potentially life threatening arrhythmias, but it uses the latest cellular technology to transmit the diagnostic information in real-time to qualified medical personnel.
Applied Cardiac Systems is expecting significant growth with the launch of the Core device. Its new analysis engine will also be available for license to companies for use in other cardiac devices. For further information about this press release or other related inquiries, please contact Christopher S. Kane at (800) 423-2929 extension 307.