AliveCor, which helps its users manage their heart health, scores another FDA approval

Last week, AliveCor, a nine-year-old, 92-person company whose small, personal electrocardiogram devices help users detect atrial fibrillation, bradycardia, and tachycardia from heart rate readings taken from their own kitchen tables, raised $65 million from investors.

Today, it’s clearer why investors — who’ve now provided the Mountain View, Ca., company with $169 million altogether —  are excited about its prospects. AliveCor just received its newest FDA approval under the agency’s software as a medical device designation for an upgrade that generates enough detail and fidelity that AliveCor says its cardiological services can now serve as stand-in for the vast majority of cases when cardiac patients are not in front of their doctor.

Specifically, the company says the FDA-cleared update can detect premature atrial contractions, premature ventricular contractions, sinus rhythm with wide QR.

In a world where the pandemic continues to rage and people remain hesitant to visit a hospital, these little steps add up. In fact, CEO Priya Abani, along with AliveCor founder and chief medical officer David Albert, formerly the chief clinical scientist of cardiology at GE, say AliveCor’s “Kardia” devices have been used to record nearly 15 million EKG recordings since March of this year, which is up over 70% year-over-year.

They also claim a 25% increase year-over-year in what they call physician-patient connections, meaning doctors specifically asking their patients to use the device, either at their medical office or at the patient’s home. Indeed, the pair says that while the company has focused historically on consumer sales, so much new business is coming through doctor referrals that roughly one out of every two of its devices is now sold through these recommendations.

Patients still need to pay out of pocket for AliveCor’s personal EKG devices, one of which currently sells for $84 while a more sophisticated model sells for $139.

The company also more recently rolled out a subscription product for $99 per year that “unlocks” additional features, including monthly summaries of a customer’s heart data, and hopefully soon, says Abani, access to cardiologists who will be able to answer questions in lieu of one’s own cardiologist.

Abani — who joined AliveCor last year from Amazon, where she was a general manager and director of Alexa — says other offerings are also in the works that should help customers measure their hypertension and blood pressure. She adds that the company more broadly sees itself as becoming a way for people to manage chronic conditions from home and that, if things go AliveCor’s way, employers will begin offering the service to employees as a way for them to take better care of their own heart health.

In the meantime, AliveCor’s bigger push into the enterprise appears tied not only to COVID and its ripple effects but also to competition on the consumer front from Apple Watch, which also now enables wearers to records the electrical pulses that make one’s heart beat and to determine whether the upper and lower chambers are their heart are in rhythm.

Though the company has sung Apple’s praises for raising awareness around heart health, last year, owing to shrinking sales, AliveCor stopped making an earlier product called the KardiaBand that was an FDA-cleared ECG wristband designed for use with Apple Watches.

AliveCor’s products are currently sold in 12 countries, including India, South Korea, and Germany, and it has clearance to sell in more than 20 others.

In addition to selling directly to customers through its site, its devices are available to buy through Best Buy, CVS, and Walgreens.

Very worth noting: Neither Apple nor AliveCor can detect actual heart attacks. While both can diagnose atrial fibrillation, acute heart attacks are not associated with atrial fibrillation.

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