InvisionHeart Receives FDA 510(k) Clearance of its InvisionECG Technology (includes video)

The U.S. Food and Drug Administration has cleared InvisionHeart Inc.’s InvisionECG technology for sale.

The 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 authorized healthcare professional has web access via an appropriate browser, according to the company. The product is designed to help diagnose cardiac disease and conditions on an earlier basis, which improves survival when “time is tissue.”

“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,” said Josh Nickols, Ph.D., president and CEO.

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,” said Susan Eagle, chief medical officer.

InvisionHeart’s ECG technology features an ultra-compact battery-powered unit with leadwires and accessories that enable clinicians to capture high-quality, digital resting 12-lead ECG data. The technology can be integrated directly with electronic health record systems to allow hospitals, clinics and long-term care facilities to merge cloud-based ECGs into existing workflows. At the center of the company’s technology is a secure cloud-based platform, InvisionConnect, which allows a network of healthcare professionals to securely access and interpret patient ECG tracings. Authorized users can access ECGs from any web-enabled device with Internet service.

“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,” noted Melanie Varin, executive vice president of Sales and Marketing.

Based in Nashville, Tenn., InvisionHeart is developing a cardiac data solution that serves clinicians who care for patients with potential heart conditions. The technology was originally developed by a team of physicians and engineers at Vanderbilt University in response to real-world clinical problems.

Find out more about InvisionHeart’s ECG system in the video below: