InvisionHeart Secures FDA Approval for ECG Technology
InvisionHeart’s electrocardiogram technology has won Class II, FDA 510(k) clearance, the Nashville, Tenn., devicemaker announced Wednesday. The company plans a launch in the third quarter of this year.
The ECG mobile system captures and manages 12-lead ECGs and provides comparisons of these readings. Data can then be viewed on browser-based, IT healthcare platform, with the hope that unrestricted web access will lead to earlier cardiac diagnosis, the company says.
Physicians will be able to provide diagnosis without having to install expensive IT infrastructure.
This is the devicemaker’s first product. InvisionHeart was founded in 2013 to provide cardiac data solutions. — Jason Scott