News | September 30, 2007

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

Related Content

Abbott Announces MR-Conditional Labeling for Quadra Assura CRT-D and Fortify Assura ICD
Technology | Cardiac Resynchronization Therapy Devices (CRT)| January 03, 2018
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Videos | Cardiac Resynchronization Therapy Devices (CRT)| May 23, 2017
This video, provided by ERB, demonstrates the function and implantation of the WiSE CRT (Wireless Stimulation Endocar
Biotronik Announces FDA Approval of MultiPole Pacing
Technology | Cardiac Resynchronization Therapy Devices (CRT)| May 11, 2017
May 11, 2017 — Biotronik announced U.S.
Biotronik Launches First FDA-Approved CRM Devices with MRI AutoDetect Technology
Technology | Cardiac Resynchronization Therapy Devices (CRT)| May 10, 2017
Biotronik announced the availability of the first U.S. Food and Drug Administration (FDA)-approved cardiac rhythm...
NICE Recommends Boston Scientific CRT-Ds With EnduraLife Battery Technology for Heart Failure Treatment
News | Cardiac Resynchronization Therapy Devices (CRT)| April 14, 2017
The National Institute for Health and Care Excellence (NICE) recently issued medical technology guidance recommending...
Biotronik, Edora series, pacemakers, CRT-Ps
Technology | Cardiac Resynchronization Therapy Devices (CRT)| March 23, 2017
March 23, 2017 — Biotronik announced the European launch of the Edora series, its smallest series of...
Overlay Init