InvisionHeart Receives FDA 510(k) Clearance of its InvisionECG Technology
NASHVILLE, Tenn.--(BUSINESS WIRE)--
InvisionHeart, a Nashville-based leading developer of a disruptive ECG technology with a secure cloud-based, healthcare IT platform, announced today that the Food and Drug Administration has cleared the InvisionECG technology for sale.
The InvisionHeart ECG System provides a revolutionary, 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. This will potentially lead to earlier cardiac diagnosis, 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,” stated Josh Nickols, PhD, President and CEO.
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’ve 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 (Association of Inpatient vs Outpatient Onset of ST-Elevation Myocardial Infarction with Treatment and Clinical Outcomes, JAMA, November 19, 2014 Volume 312, Number 19). InvisionHeart 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.
About InvisionHeart
InvisionHeart Inc. is developing a cardiac data solution that serves clinicians who care for patients with potential heart conditions. The hardware technology enables physicians, nurses, and care providers to capture, communicate, and utilize patient ECGs in a manner that is both more efficient and cost effective than the current standard of care. At the center of the technology is a cloud-based healthcare IT platform that allows a network of care providers to collaborate, review and annotate patient 12-lead ECG tracings. InvisionHeart has received 510(k) clearance by the FDA as a Class II medical technology.
For more information about InvisionHeart Inc., please see our website: www.invisionheart.com or call our main office: +1-888-674-1170.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150526006121/en/
- Health Care Industry
InvisionHeart
David Landman, 888-674-1170
Chief Operating Officer
david.landman@invisionheart.com
Help employers find you! Check out all the jobs and post your resume.
