FDA Clears Clinical Parameters, EMR for ICG

CardioDynamics recently received market clearance from the FDA for its 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. 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.