CardioDynamics 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 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. 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 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.