InvisionHeart Receives FDA Clearance for Its Mobile ECG Technology

The technology offers a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms.

The InvisionHeart, a Nashville-based //leading developer of a disruptive ECG technology, has received the Food and Drug Administration (FDA) clearance for its InvisionECG technology.

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The technology offers a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms.
(The standard 12-lead electrocardiogram is a representation of the heart's electrical activity recorded from electrodes on the body surface.)

This is all done on a browser-based, secure, healthcare IT platform. It provides access to ECGs anywhere and anytime a healthcare professional has web access through an appropriate browser. This will potentially lead to earlier cardiac diagnosis.

“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,” stated Josh Nickols, PhD, President and CEO.

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The officials with the company expect its cloud-based ECG solution to be available for clinical use in the early third quarter of 2015.

Melanie Varin, Executive Vice President of Sales and Marketing, said, “The InvisionECG system will offer significant advancement in cardiac care for patients and healthcare providers in a wide variety of care settings. Initial interest has been strong from a broad array of potential users, especially those challenged to find a high-quality, low-cost solution that is secure and fully electronic. In addition to hospitals, we’ve detected genuine enthusiasm from the rapidly growing markets for home health and ambulatory care as well as other specialty markets.”

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