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Business Update
U.S. FDA clears ICG device with 12-lead ECG
July 24th, 2005
CardioDynamics (CDIC), a leader in impedance cardiography (ICG) technology, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the second phase of the BioZ Dx - according to the company the world's first ICG device with 12-lead electrocardiography (ECG). Market release is expected during July, 2005. The BioZ Dx is the result of a codevelopment partnership between the company and Philips Medical Systems and gives physicians the ability to assess the patient's electrical and mechanical cardiovascular status in one platform. Existing BioZ Dx customers will be able to add the 12-lead diagnostic ECG...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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