Qardio this week announced that it received FDA 510(k) clearance for its QardioCore ambulatory ECG device.
QardioCore is an extension of Qardio’s remote patient monitoring platform used for primary care and hypertension monitoring to acute care and cardiology.
The device requires no special skin preparation, gels, adhesives or patches. It can be easily self-fit, removed and re-fit by a patient and does not require an in-clinic fitting.
“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,” cofounder Rosario Iannella said in a news release.
QardioCore is designed to capture continuous ECG rhythms. QardioCore and its QardioMD display full disclosure ECG reports and can be used under the care of a physician to identify arrhythmias. It is easily integrated with electronic health records and other digital health platforms and reports can be easily exported with a single click.
“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,” CEO Mark Prince said.
The company expects to launch the service in the U.S. in mid-2021 and will initially be marketed for holder monitoring applications for use with QardioMD.