Vanderbilt Startup InvisionHeart receives FDA clearance

Our congratulations to the InvisionHeart team for obtaining FDA 510(k) clearance for its secure, cloud-based, mobile solution for capturing and managing 12-lead ECGs. This clearance will permit InvisionHeart to sell its product. The InvisionHeart product is a significant advancement in cardiac care for patients and healthcare providers in a wide variety of care settings. The product is cost-effective, increases access and decrease cycle time while filling a critical unmet need of diagnosing cardiac disorders without the need for purchasing expensive IT infrastructure – a significant accomplishment for the medical care industry.

This is an important milestone for the company. We are very appreciative of the hard work of Josh Nichols, Susan Eagle and other members of the InvisionHeart management team.

This technology was developed by a collaborative team lead by Franz Baudenbacher, Ph.D., associate professor of Biomedical Engineering and Susan Eagle, M.D., associate professor of Clinical Anesthesiology. The pair discuss their unique partnership and how it has enabled them to find innovative solutions to challenges faced in the medical field. Watch the power of collaboration video:

The technology was licensed exclusively to InvisionHeart in 2013. In a 2014 video, Josh Nickols, PhD, CEO of InvisionHeart, shares his thoughts on what it's like to work with CTTC