Direct-to-Consumer Heart Health Devices: Present and Future

Published - Written by HeartBeam

Direct-to-consumer heart monitoring devices have been on the market since 2014 and have grown considerably in popularity. A recent article entitled “Should you get an Apple Watch® for your Heart” made clear that personalized, instant health-related information is in high demand — from fitness trackers to genetic tests. The Apple Watch, coupled with the iPhone, already doubles as a fitness tracker, allowing users to track physical activity and sleep habits, but the latest version may also be used to track heart rhythms in order to suggest the possible presence of atrial fibrillation (Afib), an arrhythmia that can lead to a stroke.

While these devices are convenient for consumers and provide useful information, they are not cleared to diagnose a medical condition in isolation without a physician. This is true even for Afib. Further, the potential influx of data may include many false positives, making them a management challenge for technology companies and healthcare providers alike. So, what are the key elements of a mobile Health cardiovascular technology that will save lives AND save healthcare dollars?

1. User friendly. In order to address a heart health issue outside of a medical institution, every technology will have to collect cardiac signals. All technologies that require a special set of wires and electrodes to be carried by a user/patient fail this requirement.

2. 12 lead ECG equivalent. All user-friendly mobile cardiac technologies in the market today are based on single-lead ECG. While they may be sufficient for detecting some arrhythmias, they fall well short of capabilities of the standard 12 lead ECG. A comprehensive mobile cardiac technology must be capable of collecting a 12 lead ECG equivalent set of signals.

3. Diagnostic engine mimicking a cardiologist. The collection of cardiac signals is not enough. A software-based integrated (including symptoms) diagnostic engine is a must to ensure that physicians are not overwhelmed by patients’ field transmissions.

4. Diagnostic performance was equal to or better than a cardiologist. In order to satisfy the requirement of sensitivity (false negative rate) and specificity (false positive rate), a consumer mobile health technology needs to demonstrate diagnostic performance that is equal to or better than a physician. If those criteria is met, one can rightfully make the claim that technology offers “a physician diagnosing your conditions instantly 24/7”. How can any argument be made against this value proposition?

By combining these four attributes, a solution like HeartBeam’s iCardiologist™ will save lives and reduce the number of unnecessary medical exams, thereby significantly reducing healthcare expenses in the cardiac field. HeartBeam’s iCardiologist’s mobile Health cardiac solution truly satisfies all the above criteria to bring - once cleared by the FDA - a major positive impact to cardiac patients, insurance companies and physicians. Over time, the anonymized, HIPAA-compliant data from millions of individual ECGs will also provide immense research value to biotech and pharma firms.

We are working with RedCrow, an online fundraising platform and digital due diligence deal room, on a $1.2 million target campaign to accelerate the FDA process. Visit to learn more.