Cambridge Heart has completed the development phase of its Microvolt T-wave Alternans (MTWA) OEM Module, and has submitted a 510(k) application for regulatory approval with the FDA. The module is the centerpiece of the company’s new business model that involves partnering with leading stress test equipment manufacturers to broaden the distribution and use of MTWA technology.
“We are very pleased with our progress and pace in achieving this important milestone,” said Ali Haghighi-Mood, Cambridge Heart’s President and CEO. “With the completion of the development work and our FDA regulatory submission, we are one step closer to making our Microvolt T-wave Alternans technology available to more physicians and their patients.”
The MTWA test, administered in much the same way as a stress test, is a non-invasive 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.