Qardio has announced that the US Food and Drug Administration (FDA) has granted the company 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio’s cloud-based remote patient monitoring solution.
QardioCore extends Qardio’s remote patient monitoring platform from primary care and hypertension monitoring to acute care and cardiology, in a single, intuitive platform, the company said in a press release.
Qardio co-founder Rosario Iannella, said: “Our goal for QardioCore has always been to create a better experience for patients and care providers. For patients, there is much less inconvenience in comparison to traditional monitors. For providers, patient usability leads to compliance – so QardioCore can deliver high diagnostic yields by design.”
QardioCore is intended to capture continuous ECG rhythms. QardioCore and QardioMD display full disclosure ECG reports and may be used under the care of a physician to identify arrhythmias. QardioMD is easily integrated with EHRs and other digital health platforms.
Qardio CEO Mark Prince added: “Our initial ECG service has been designed for remote deployment and works right out of the box. Patients will find that QardioCore is as easy to use as a common heart rate monitor, but with the power of an ECG, to relay rhythms to a full disclosure presentation in QardioMD. QardioCore enables providers to receive telemetry in as little as 24 hours, which can dramatically accelerate time to diagnosis.”
