InvisionHeart receives FDA 510(k) clearance of its InvisionECG technology


The US Food and Drug Administration (FDA) has cleared InvisionHeart’s InvisionECG technology for sale in the USA.

InvisionHeart says that its InvisionHeart ECG system provides 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. This is all done on a browser-based, secure, healthcare IT platform which provides access to ECGs anywhere and anytime an authorised healthcare professional has web access via an appropriate browser. This will potentially lead to earlier cardiac diagnosis, which improves survival when “time is tissue.”

Josh Nickols, president and chief executive officer, 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.”

The company expects 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, added, “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 have detected genuine enthusiasm from the rapidly growing markets for home health and ambulatory care as well as other specialty markets.”

Striking new data (in both the Journal of the American Heart Association and the Journal of the American Medical Association) has identified a delay in cardiac diagnosis within the hospital setting that is associated with increased mortality. “If you have a heart attack while in a hospital, your chances of dying are three-fold greater than those with outpatient-onset heart attacks,” indicated Susan Eagle, chief medical officer based on a JAMA report. InvisionHeart says that it offers a cost-effective technological solution with the potential to increase access and decrease cycle time while filling a critical unmet need of diagnosing cardiac disorders without the need for purchasing expensive IT infrastructure.