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Cambridge Heart Files 510(K) For New MTWA Module

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 the company’s new business model that involves partnering with stress test equipment manufacturers to broaden the distribution and use of MTWA test.

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 risk factor for sudden cardiac arrest.

Ali Haghighi-Mood, president and CEO of Cambridge Heart, said: “We are pleased with our progress and pace in achieving this important milestone. 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.”

Cambridge Heart develops and commercialises non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The company’s products incorporate proprietary Microvolt T-Wave Alternans measurement technologies, including the patented Analytic Spectral Method(R) and ultrasensitive disposable electrode sensors.