February 11, 2010 – Changing direction from a standalone device technology, Cambridge Heart Inc. has developed an OEM module to incorporate its microvolt T-wave alternans technology into other vendor’s ECG stress test equipment.
The development phase of a microvolt T-wave alternans (MTWA) OEM module has been completed and an FDA 510(k) application for regulatory approval has been filed.
The MTWA test, administered in much the same way as a stress test, is a noninvasive diagnostic tool that can identify the presence of a subtle alternating pattern in the ECG, which has been shown to be a significant risk factor for sudden cardiac arrest.
For more information:www.cambridgeheart.com.