FDA grants AliveCor first-ever clearance for smartphone ECG

AliveCor announces the launch of KardiaMobile 6L, the world’s first six-lead consumer heart monitoring device to get FDA approval.

Using your phone to prevent strokes and cardiac anomalies may sound like a strange idea, but with new digital health devices, it may soon become a reality. The launch of AliveCor’s KardiaMobile 6L is one prime example and the new smartphone-based heart monitoring device was recently given the green light by the FDA.

But with a handful of cardiac-centric digital health devices already on the market, what makes this one so different? This new model uses six ECG leads (rather than the one or two commonly found on other direct-to-consumer devices) to create a multi-dimensional image of the heart in 30 seconds. KardiaMobile 6L is proof that technology is taking one step closer to consumers having more control and depth when it comes to monitoring their own health.

Longevity.Technology: There are quite a few personalised heart monitoring devices on the market; what AliveCor touts as its key innovation is its ‘six-lead’ system, which can take six different scans for greater accuracy. How much of a threat to traditional hospitals scans this poses, however, is hard to define. Many could use the technology to supplement the care they receive from doctors, but it is much harder to see it becoming a primary diagnostics choice any time soon. The move towards greater sophistication does make this more realisable, however.

The TRL score for this Longevity.Technology domain is currently set at: ‘Technology has completed initial trials and demonstrates preliminary safety data.’

The TRL score for the technology addressed in this article is: “Regulatory approval takes place and product is available to market.”

“By providing physicians with six different views of the electrical activity of the heart, KardiaMobile 6L offers a much greater chance of detecting a broad range of arrhythmias and other hearth conditions than a single-lead device,” said Matthew Reed, a Consultant in Emergency Medicine at The Royal Infirmary of Edinburgh [1]. “If everyone with unexplained heart rhythm symptoms used a pocket-sized heart monitor, it would cut costs, speed diagnosis and avoid preventable hospital admissions.”

This new mobile application targets cardiac conditions, mostly aimed at Atrial Fibrillation (AF), a common form of arrhythmia, which was found to be the leading cause of strokes.  Someone suffers from an AF-related stroke every 15 seconds in the UK, meaning that new technology could not only cut down the alarming number of cases, but also take pressure off the UK National Health Service (NHS), which spends approximately £3 billion a year on treatments [2].

The KardiaMobile 6L, which is available to order on Amazon UK for £149, is similar in design and function to the single-lead device. The user starts an ECG recording on their smartphone by placing their thumbs on each of the top two wireless electrodes and the bottom electrode on their left knee or ankle. Once paired to the Kardia smartphone app, the artificial intelligence system conducts an automatic analysis to detect AF and other heartbeat irregularities—including tachycardia and bradycardia. The collected data can then be sent directly to a clinician for further consultation.

The Silicon Valley-based company has received $64 million in funding to date, but is not seeking further investment and has no IPO plans in sight. AliveCor has produced another product in this space – an Apple Watch compatible ECG wristband that was recently discontinued, as the Apple Watch Series 4 revealed their new version would include ECG functionality. Although, for most this would seem to put the companies in competition with each other, Chief Commercial Officer Ira Bahr has told reporters this is not the case as theirs is only a single-lead product. Their real competition seems to lie in companies such as Withings and Samsung, who are considering devices with some of the same functions as AliveCor in their own products.

AliveCor’s previous experience in digital health technology and the new FDA approval have quickly moved this product into the market, building more momentum for digital health and improving healthspan. Although, its safety and efficacy are no longer a question, the real impact of the product on the consumers and the digital health market is still to be seen.

[1] https://prn.to/2ng1rQo
[2] https://www.england.nhs.uk/2019/05/nhs-stroke-action-will-save-hundreds-of-lives/

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