Six-Lead, Consumer-Facing ECG Device Close to Release to Market

I have previously blogged about AliveCor's three-lead ECG device in particular and cardiology in general as examples of cardiology being a "collision point" between consumer IT and the healthcare system (see: Three New Studies Confirm Clinical Utility of AliveCor’s KardiaMobile Device and AI Algorithms; Cardiology as a "Collision Point" between Consumer IT and the Healthcare System). The company is now testing a a six-lead ECG instrument (see: AliveCor previews next product: A 6-lead smartphone ECG). Here is an excerpt from this article:

AliveCor, which has offered an smartphone-connected ECG since 2012 and a wristworn version since 2016, revealed...the company’s next direction: a six-lead ECG compatible with a smartphone.....The device is not yet cleared by the FDA...[and] codenamed Project Triangle, looks similar to AliveCor’s existing Kardia Mobile device....But in addition to the two electrodes on the front of the device, there’s an additional one on the back. The user places on thumb on each of the top electrodes and places the bottom electrode on their left knee. This formation — known in cardiology as an Einthoven Triangle after Willem Einthoven, the inventor of the electrocardiograph — allows cardiologists to view electronic activity in the heart from six angles, or leads. With these, the device can potentially catch the warning signs of an upcoming heart attack.....Both AliveCor’s existing products...are single-lead ECGs, as are most similar devices on the market.

Here's a tweet from Dr. David Albert from May 10, 2019 about this new six-lead device:

I am proud that our new @AliveCor KardiaMobile 6L provides a new level of diagnostic cardiac rhythm information. Thanks to Dr. Topol for helping us evaluate and validate this new clinical capability.

This consumer-facing ECG instrument is a good example of the development arc of such products over the period of about seven years in the case of KardiaMobile. It's a story of increasing diagnostic functionality to the point, now or in the near future, when it will loop back to even be deployed by cardiologists in certain clinical settings. Cardiologists may find it more efficient to use the device in their office or ED rather than the standard instrument to obtain an answer quickly. In some developing countries, it may be the only ECG instrument available because of cost. A similar story applies to portable ultrasound devices that utilize the screen of a smart phone (see: Wireless Portable Ultrasound). Here's my note on the topic of portable ultrasound devices from almost thirteen years ago (see: Portable Ultrasound Devices Introduced into Medical School Curriculum). It should be emphasized that the KardiaMobile devices are equipped with AI to interpret the tracings for consumers. This AI feature obviously will not be required by the cardiologists who use it.