Technology | February 13, 2014

AliveCor Heart Monitor Receives Over-the-Counter Clearance

Provides individuals a way to participate in their heart health

AliveCor Heart Monitor FDA EP Lab ECG Cardiac Diagnostics Mobile Remote
February 13, 2104 — The U.S. Food and Drug Administration (FDA) granted AliveCor Inc. over-the-counter (OTC) clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only. The device is available for pre-order purchase with shipments beginning in March.
 
The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost. Health professionals and patients have reported using the device to detect, monitor and analyze irregular heart rhythms.
 
The AliveCor Heart Monitor’s medical-grade ECG recordings can be shared directly with a user’s physician, or sent to a U.S. board-certified cardiologist or a U.S. based cardiac technician. It does so through AliveInsights, an analysis service that offers expert review of ECGs directly through the free AliveECG app. Recordings are then reviewed and analyzed providing users with a more complete picture of their current heart health.
 
The AliveCor Heart Monitor is a FDA cleared mobile ECG recorder that supports both iPhone and Android smartphones. It records, displays, stores and transfers single-channel ECG rhythms wirelessly. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. The Heart Monitor is available for purchase in the United States by health professionals, patients with prescriptions and now over-the-counter.
 
For more information: www.alivecor.com

Related Content

The BardyDx Carnation Ambulatory Monitor (CAM) is a P-wave centric wearable ambulatory cardiac patch monitoring and arrhythmia detection device. 

The BardyDx Carnation Ambulatory Monitor (CAM) is a P-wave centric wearable ambulatory cardiac patch monitoring and arrhythmia detection device. 

News | Cardiac Diagnostics | July 29, 2021
July 29, 2021 — A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation Ambula
The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

News | Cardiac Diagnostics | July 01, 2021
July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc.
Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Detecting heart disease with OCT imaging of the eye.Getty Images

Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Getty Images
 

News | Cardiac Diagnostics | March 08, 2021
March 8, 2021 — In a new study from Shiley Eye Institute at UC San Diego Health, researchers have identified a potent
Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia.

Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG strip on a smartphone. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia. 

News | Cardiac Diagnostics | March 03, 2021
March 3, 2021 — AliveCor recently announced a new collaboration with AstraZeneca to research new disease management s
A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images Health disparities in cardiovascular disease.

A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images

News | Cardiac Diagnostics | February 02, 2021
February 2, 2021 — A new study has found in the U.S.
A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

News | Cardiac Diagnostics | January 06, 2021
January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects
The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia.

The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia. 

News | Cardiac Diagnostics | October 06, 2020
October 6, 2020 — A new technology being developed by U.S.-based Mesuron Inc.
With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en