FDA clears KardioMobile, a personal ECG device to detect rhythm disorders

The Food and Drug Administration (FDA) has cleared KardiaMobile which is a personal ECG device that can be used for detecting rhythm disorders like bradycardia and tachycardia.

KardiaMobile detects Atrial Fibrillation, Bradycardia, Tachycardia, as well as Normal Sinus Rhythm. And KardiaMobile powers KardiaPro, the free Remote Patient Monitoring platform that allows your practice to harness your patients’ reports simply, without data overload.

While first generation monitoring systems are challenging to navigate and difficult to monetize, KardiaPro presents data in a simple, intuitive format designed to conform with CPT reimbursement code requirements.

KardiaPro is a web‑based portal that presents medical‑grade patient data from the most clinically validated and widely used ECG and blood pressure monitoring devices in the world. KardiaPro is used by providers to support clinical decision making. Actionable data is organized and triaged based on customized practice parameters for efficiency. KardiaPro is completely free to your practice with no hardware to buy or sell.

• KardiaPro allows physicians to deliver a higher quality of care to more patients.


• Physicians are able to avoid unneeded in-person visits.


• Physicians are able to spend more time with patients who truly need their expertise.

This portable EKG reader, which works with smartphones and tablets, was first cleared by the FDA in 2017 for detection of normal sinus rhythm and atrial fibrillation. When paired with the Kardia app, the device now provides instant analysis for 3 of the most common cardiac arrhythmias. Through the KardioPro platform, clinicians are able to remotely monitor patients, which the Company believes helps support clinical decision making and may help reduce unneeded in-person visits.