FDA widens coronary calcium software use
Vital Images has received 510(k) FDA clearance for a new option to its VScore product that allows the software to be used with helical CT scanners made by GE Medical Systems, potentially opening a much larger market for coronary artery calcium
Vital Images has received 510(k) FDA clearance for a new option to its VScore product that allows the software to be used with helical CT scanners made by GE Medical Systems, potentially opening a much larger market for coronary artery calcium imaging.
The option, called "VScore with EKG Gate," uses an alternative measurement process. VScore and VScore with EKG Gate are integrated options with Vital Images' Vitrea 2 3-D visualization and analysis software.
Multislice helical scanners have driven growth in the use of calcium scoring as a screening method for coronary artery disease. Calcium scoring was originally developed as a fast and inexpensive diagnostic aid using electron-beam computed tomography (EBCT) scanners, according to Vital Images' senior vice president and general manager Jay Miller.
Calcium is a primary component of arterial plaque, which can indicate development of atherosclerosis and serious coronary problems in the future.
Miller said the Windows-compatible VScore and Vitrea 2 software can be adapted for use with any manufacturer's scanners.