CardioDynamics Receives FDA Clearance for Clinical Parameters and EMR
September 28, 2007 - CardioDynamics said it received market clearance from the FDA for its new BioZ Impedance Cardiography (ICG) clinical parameters and electronic medical record (EMR) interface capability for its BioZ Dx System.
The BioZ Dx is the product of a co-development partnership between the company and Philips Medical Systems that leverages each company’s technology and expertise.
The new ICG clinical parameters include total arterial compliance (TAC) and Q-C time interval (QC). TAC allows the assessment of peripheral artery elasticity, an early marker of peripheral artery and cardiovascular disease. Monitoring TAC may allow earlier identification of cardiovascular risk not apparent with standard tools, including blood pressure assessment, and earlier therapeutic intervention which has been proven to delay or prevent cardiovascular disease progression. QC has been demonstrated to offer enhanced assessment of cardiac contractility. The company's early clinical investigations have shown enhanced association with more costly, but advanced cardiac diagnostic evaluation, including ejection fraction. The company said these parameters may contribute to earlier and more cost-effective evaluation of heart failure, the most costly disease for Medicare.
The company also announced FDA 510(k) clearance for expanded BioZ Dx EMR interface capability. By improving medical practice efficiency and patient safety, EMR is viewed as a valuable component of the healthcare system. EMR has been at the center of legislative discussions, with Congress and the Department of Health and Human Services working to link Medicare reimbursement to EMR processing. This has resulted in an increasing demand by physician offices for EMR capability. The BioZ Dx EMR interface is designed to operate in conjunction with the company's proprietary PC software, BioZport, which automatically sends BioZ ICG clinical data to the customer's local PC network in one of three industry-accepted formats. The data can then be easily integrated into each patient's electronic medical record.
For more information: www.cdic.com