Qardio’s Ambulatory ECG Device Cleared by FDA

The FDA has given 510(k) clearance for Qardio’s QardioCore, an ambulatory electrocardiogram (ECG) device.

The device, which is intended for remote use, does not require any gels, adhesives, patches or skin preparation. It can also be self-fit, refitted and taken off by the patient without the need for fitting in a clinic.

The system relays patient rhythms to QardioMD, the company’s cloud-based remote patient monitoring service, enabling providers to view patient telemetry data.