Cambridge Heart wins FDA 510(k) clearance for OEM cardiac test
April 15, 2010 by MassDevice staff
Cambridge Heart Inc.'s plan to enter the original equipment manufacturing market gets a big boost as the Food & Drug Administration grants 510(k) clearance to its MTWA heart testing module.
Cambridge Heart Inc. (OTC:CAMH) won a much-needed nod from the Food & Drug Administration when the watchdog agency cleared an OEM version of its microvolt T-wave alternans cardiac monitor.
The 510(k) clearance means the Tewksbury, Mass.-based firm can move forward with a deal it struck last year with Cardiac Science Corp. (NSDQ:CSCX) to incorporate the MTWA device into Cardiac Science's Q-Stress line of heart stress-testing equipment.
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