FDA Clears Clinical HF Parameters, EMR Compatibility
October 1, 2007 - CardioDynamics announced it has received market clearance from the FDA for new ICG clinical parameters and electronic medical record (EMR) interface capability for its BioZ Dx System, which the company hopes will contribute to earlier and more cost-effective evaluation of heart failure.
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. Early clinical investigations have reportedly shown enhanced association with more costly, but advanced cardiac diagnostic evaluation, including ejection fraction.
The FDA 510(k) clearance for expanded BioZ Dx EMR interface capability is designed to improve medical practice efficiency and patient safety. 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 reportedly be integrated into each patient’s electronic medical record.
For more information: www.cdic.com