Technology | May 28, 2015

FDA Clears InvisionHeart Mobile ECG Technology

Device uses secure cloud-based platform to capture, report and store diagnostic-quality ECGs

InvisionHeart, InvisionECG, FDA clearance

Image courtesy of InvisionHeart

May 28, 2015 — The U.S. Food and Drug Administration (FDA) has cleared the InvisionECG technology from InvisionHeart. The mobile electrocardiogram (ECG) technology uses a secure cloud-based, healthcare IT platform to capture and manage 12-lead ECGs.

The system offers the ability to read and visually compare, confirm, report and store diagnostic-quality ECGs. This is all done on a browser-based, secure, healthcare IT platform which provides access to ECGs anywhere and anytime an authorized healthcare professional has Web access via an appropriate browser. This will potentially lead to earlier cardiac diagnosis, which improves survival when “time is tissue.” New data in both the Journal of the American Heart Association and the Journal of the American Medical Association has identified a delay in cardiac diagnosis within the hospital setting that is associated with increased mortality.

The company expects its cloud-based ECG solution to be available for clinical use in the early third quarter of 2015.

For more information: www.invisionheart.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