AliveCor Receives FDA Approval - Heart Health Management

AliveCor, a nine-year-old firm with a team of 92 individuals, recently secured $65 million in funding from investors. This company specializes in compact, personal electrocardiogram (EKG) devices that empower individuals to identify atrial fibrillation, bradycardia, and tachycardia through heart rate measurements taken conveniently at home.

Today, the rationale behind this investor confidence – totaling $169 million to date – is becoming increasingly apparent. AliveCor has just received a new FDA clearance, classifying an upgrade as a medical device software. This advancement provides a level of detail and accuracy that allows AliveCor’s cardiological services to effectively substitute for traditional cardiac evaluations in the majority of cases when patients are not physically present with their physician.

More specifically, the FDA-approved update is capable of identifying premature atrial contractions, premature ventricular contractions, and sinus rhythm with a wide QRS complex.

Amidst the ongoing pandemic and continued reluctance to visit healthcare facilities, these advancements are proving significant. According to CEO Priya Abani and founder/chief medical officer David Albert – formerly the chief clinical scientist of cardiology at GE – AliveCor’s “Kardia” devices have recorded almost 15 million EKGs since March, representing a more than 70% increase compared to the previous year.

The company also reports a 25% year-over-year rise in physician-patient connections, indicating that doctors are increasingly recommending the use of these devices to their patients, both in clinical settings and at home. While AliveCor initially focused on direct consumer sales, a substantial portion of new business now originates from physician referrals, with approximately half of all devices being sold through these recommendations.

Consumers continue to purchase AliveCor’s personal EKG devices directly, with current pricing at $89 for a standard model and $139 for a more advanced version.

A recently introduced subscription service, available for $99 annually, unlocks additional features, including monthly summaries of heart data and, potentially in the near future, access to cardiologists for consultation, offering an alternative to contacting one’s primary cardiologist.

Abani, who joined AliveCor last year after serving as a general manager and director of Alexa at Amazon, states that further developments are underway to enable customers to monitor their hypertension and blood pressure. The company envisions itself as a platform for managing chronic conditions remotely, with the potential for employers to offer the service to employees as a proactive heart health benefit.

AliveCor’s increased focus on enterprise solutions appears to be driven not only by the effects of COVID-19 but also by competition from the Apple Watch, which now also allows users to record electrical heart activity and assess heart rhythm.

Despite acknowledging Apple’s contribution to raising awareness about heart health, AliveCor discontinued its KardiaBand – an FDA-cleared ECG wristband designed for Apple Watches – last year due to declining sales.

AliveCor’s products are currently available in 12 countries, including India, South Korea, and Germany, with regulatory clearance for sale in over 37 countries overall.

In addition to direct sales through its website, the devices can be purchased at retailers such as Best Buy, CVS, and Walgreens.

It is important to note that neither Apple nor AliveCor devices can detect actual heart attacks. While both are capable of detecting atrial fibrillation, heart attacks are not typically associated with this condition.