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Home » Cambridge Heart asks FDA for 510(k) clearance for OEM device

Cambridge Heart asks FDA for 510(k) clearance for OEM device

February 11, 2010 By MassDevice staff

Cambridge Heart Inc. (OTC:CAMH) took another step forward with its strategy to bring an OEM version of its flagship cardiac testing device to market, asking the Food & Drug Administration to approve the latest version of its microvolt T-wave alternans module.

Last summer, the Tewksbury, Mass.-based firm announced its plan to shift to a new marketing model for the non-invasive device, which it says can help predict the risk of sudden heart attack. Rather than focusing on sales to physicians and hospitals, Cambridge Heart said it would look to develop an OEM version that other manufacturers could incorporate into their own products.

About five months after its June announcement of the new strategy, the company revealed a deal with Cardiac Science Corp. (NYSE:CSCX) to incorporate the MTWA device into that company’s stress test system. Cambridge Heart said the new module is the centerpiece of its new business model, as it looks to partner with CSCX and other stress test makers.

CAMH pared its net losses by 20 percent during the third quarter, despite posting a 29 percent slide in Q3 sales, reporting net losses of $1.7 million on sales of $798,000 for the three months ended Sept. 30, compared with net losses of $2.1 million on sales of $1.1 million during the same period last year.

Filed Under: Business/Financial News, Food & Drug Administration (FDA), News Well Tagged With: Cambridge Heart Inc.

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