News | April 22, 2011

Urgent Care Solution Shown to be More Accurate in Diabetic Patients

April 22, 2011 – The American Diabetes Association (ADA) has invited NewCardio to present the results of a key study of the company’s urgent care solution, my3KG. Results showed that the solution had substantially greater accuracy than expert cardiologists' interpretation of standard 12-lead ECG (12L ECG) in diagnosing acute myocardial infarction (AMI) in diabetic patients.

The presentation will be made at the 71st Annual ADA Scientific Sessions to be held in San Diego, Calif., June 24-28, 2011. In addition, the ADA has selected this presentation to be showcased in the Guided Audio Poster Tour, which features expert moderators that share their perspectives with attendees, highlighting novel and important developments in the field.

"We are delighted to present our study results at this important gathering of diabetes experts, and particularly pleased that the ADA program committee chose to feature our presentation in a moderated poster session,” said Ihor Gussak, M.D., Ph.D., NewCardio's chief medical officer. “Accurate and timely AMI diagnosis is a matter of great concern for diabetologists, and we believe our results show that my3KG can play a major role in solving it. The moderated poster session provides the opportunity to present our results directly to leading diabetes experts, and have one-on-one interactions that will allow us to discuss and explain the importance of our results in detail."

Diabetics with AMI represent a very large and growing patient group, and currently affect more than 10 percent of adults in the United States. Moreover, the incidence of AMI is two to four times greater in diabetics than in the general population, according to ADA and American Heart Association statistics. Accurate and timely diagnosis of AMI is notoriously difficult in diabetics, largely because the standard 12L ECG is often inaccurate, inconclusive or non-diagnostic in this patient group. To address this problem, investigators at the University of Kansas Medical Center, in collaboration with NewCardio physician-scientists, obtained detailed clinical and 12L ECG data on 155 consecutive diabetic patients with suspected AMI, and evaluated the diagnostic performance of my3KG in this patient group.

The study showed that my3KG had 42 percent greater sensitivity than expert cardiologist interpretation of 12L ECG for early detection of AMI, with equal or better specificity. Based on these important results, NewCardio believes use of my3KG in this patient group may facilitate more accurate and timely diagnosis of AMI in diabetic patients, thereby improving clinical outcomes.

The 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12L ECG. NewCardio is developing the my3KG solution for urgent diagnosis of serious cardiac conditions, including AMI. In clinical studies to date, the my3KG has shown substantially improved diagnostic accuracy relative to the standard 12L ECG, particularly in the most diagnostically challenging patients.

The my3KG is not currently marketed for sale in the United States. The company intends to file an application for 510(k) approval with the U.S. Food and Drug Administration (FDA) in 2011/2012.

For more information: www.newcardio.com

Related Content

FDA Clears AliveCor's KardiaMobile 6L as First Six-Lead Personal ECG Device
Technology | ECG | May 13, 2019
AliveCor announced its third U.S. Food and Drug Administration (FDA) clearance in three months, making KardiaMobile 6L...
One innovation in ECG is its use in the customer wearable market, which will tie more closely into the clinical world either with using the data to triage patients and/or patients seeking medical attention prior to acute symptoms appearing.

One innovation in ECG is its use in the customer wearable market, which will tie more closely into the clinical world either with using the data to triage patients and/or patients seeking medical attention prior to acute symptoms appearing.

Feature | ECG | May 03, 2019 | Sanket Solanki
Technology has made its way into the healthcare sector and brought a drastic transformation.
Videos | ECG | March 05, 2019
This is a quick demo of the Schiller Cardiovit FT-1 electrocardiograph (ECG) system displayed at the ...
EKG With Artificial Intelligence Reliably Detects Heart Failure Precursor
News | ECG | January 08, 2019
January 8, 2019 — A Mayo Clinic study finds that applying...
Use of traditional Holter monitor leads can be an issue for patient compliance and comfort. The newer generation ambulatory cardiac monitors use an adhesive patch that sticks directly on the patient's chest and allows them to shower and go about daily activities without a belt mounted monitor or leads getting in the way. This is especially important for longer term monitoring of seven days or longer.

Use of traditional Holter monitor leads can be an issue for patient compliance and comfort. The newer generation ambulatory cardiac monitors use a small, adhesive patch that sticks directly on the patient's chest and allows them to shower and go about daily activities without a belt mounted monitor or leads getting in the way. This is especially important for longer term monitoring of seven days or longer. 

Feature | ECG | September 27, 2018
Advances in the technology of wearable cardiac monitors are improving both the experience of the patient and the effe
HeartSciences MyoVista ECG Device Shows Promise in Detecting Abnormal Cardiac Function
News | ECG | April 27, 2018
HeartSciences announced the results of a clinical study of its electrocardiography device that applies continuous...
ECG Study of NBA Players Shows Need for Sport-Specific Normative Data and Guidelines
News | ECG | December 08, 2017
Cardiologists at NewYork-Presbyterian/Columbia University Irving Medical Center compared electrocardiographic findings...
HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle.

News | ECG | August 22, 2017
HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device...
AUM Cardiovascular Receives FDA Approval for CADence ECG Device
Technology | ECG | August 08, 2017
AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a...
More Than 20 Percent of Low-Risk Patients Receive Annual ECG
News | ECG | July 20, 2017
July 20, 2017 — More than one in five Ontario patients receive an ...
Overlay Init