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Cambridge Heart Receives FDA Clearance For MTWA Module

Cambridge Heart has received clearance from FDA to begin marketing of Microvolt T-Wave Alternans (MTWA) OEM module that is designed to work with existing cardiac stress test platforms distributed by other manufacturers.

The FDA 510(k) clearance allows Cambridge Heart to begin marketing the MTWA OEM module integrated with the Q-Stress line of stress systems manufactured by Cardiac Science Corp. The non-invasive MTWA test measures small heartbeat irregularities that indicate a patient’s heightened risk for sudden cardiac arrest.

Reportedly, in June 2009, Cambridge Heart and Cardiac Science have entered into a five-year development and distribution partnership, whereby Cardiac Science will market the MTWA OEM module to its existing base of installed stress systems as an upgrade, and to new stress customers as an optional feature. The development of the MTWA OEM module was completed in early February 2010.

Dave Marver, president and CEO of Cardiac Science, said: “The development of MTWA as an add-on module for our stress systems allows us to bring new technology to our customers and extend our leadership in the stress segment. The initiative is consistent with our goal to help our physician customers by offering simple, cost-effective, and efficient devices that improve public health.”

Ali Haghighi-Mood, president and CEO of Cambridge Heart, said, “We are pleased to have reached this important milestone in a relatively short period of time. Obtaining the FDA clearance is a big step as we implement our new business model that aims to market the MTWA technology via partnerships with the leading stress test manufacturers.

“Most immediately, the clearance allows us to focus our activities on working with Cardiac Science, training its sales force and distributors and engaging in other activities in advance of the product launch.”