InvisionHeart said it won 510(k) clearance from the FDA for the commercial sale of its InvisionHeart electrocardiogram system.
The InvisionHeart ECG system is designed to help manage and capture 12-lead ECGs, the company said, allowing physicians to visually compare, report on and store high-quality electrocardiograms. The system is cloud-based and can be accessed through a browser-based interface, InvisionHeart 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," executive vice president of sales & marketing Melanie Varin said in a press release.
The cloud-based ECG system is expected to be available for clinical use in the early 3rd quarter of 2015, the company 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," added CEO Josh Nickols.