US-based InvisionHeart has obtained 510(k) approval from the US Food and Drug Administration (FDA) to market its InvisionECG technology.
The InvisionHeart ECG System offers mobile solution to capture and manage 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms.
InvisionHeart president and CEO Dr Josh Nickols said: "This is a significant milestone in the development of our technology and, more importantly, a breakthrough in our ability to serve patients where ECGs have been traditionally unavailable.
"Earlier diagnosis of cardiac issues via improved access will benefit patients, whether in the hospital setting or at home."
According to the company, the system can be used on a browser-based healthcare IT platform that provides access to ECGs anywhere and anytime for an authorized healthcare professional, who has web access through an appropriate browser.
The company plans to introduce the cloud-based ECG solution for clinical use in the early third quarter of this year.
InvisionHeart sales and marketing executive vice-president Melanie Varin said: "The InvisionECG system will offer significant advancement in cardiac care for patients and healthcare providers in a wide variety of care settings."