New 510(k) notification offers more clues on AliveCor's next moves

The company has received multiple clearances as it gears up for the release of its next-generation smartphone-connected ECG platform.
By Dave Muoio
01:33 pm

Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products.

According to the agency, the digital health company received clearance related to its consumer KardiaMobile platform, as well as the clinician-facing KardiaStation, on Friday. The application for the device or devices was received in September of last year.

AliveCor declined MobiHealthNews’ request for comment on the agency’s notification. However, the company has in the past been fairly forthcoming about its work on a second-generation KardiaMobile, a six-lead ECG that would also be compatible with users’ smartphones. AliveCor first teased this product in the days following Apple’s entry into the mobile ECG market, with interim CEO Ira Bahr sharing a bit more on the company’s upcoming products in February.

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“I think we’re going to do more in the next six months than we have in the last six years,” he said at the time. “That includes a certain hopefulness about the speed of FDA clearance, but we’ve got a bunch of things in the pipeline, including the six-lead product and an additional indication that we hope to be able to fully market in the first half of the year.”

This hasn’t been the company’s only mysterious clearance in recent days. Another product called the KardiaAI was approved in March, which a recent update to the FDA’s prior database listing now describes as “a software analysis library” that “supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices.” Listed among the tool’s capabilities is noise filtering, heart rate measurement and ECG rhythm analysis for detecting, when prescribed or used professionally, normal sinus rhythm, atrial fibrillation, bradycardia and tachycardia.


Taken together, AliveCor’s prior comments and this new info from the FDA make it clear that the company’s next move will be more than a slight tweak to its existing hardware. And although AliveCor markets its mobile ECG devices to consumers, researchers have also highlighted the technology’s potential as a low-cost, portable tool for providers treating patients with heart conditions.


Alongside the clearances, AliveCor’s platform was highlighted in a number of research studies presented at the American Conference of Cardiologists in March, one of which was a Mayo Clinic investigation of the second-generation device.

The last few months also saw former CEO Vic Gundotra step down from his position as the company’s head, citing personal reasons, and an announcement that the company had received debt funding from Oxford Finance to secure its continued growth.

And, as mentioned before, AliveCor’s devices are seeing stiff competition from the latest version of the Apple Watch, which received its own ECG reading and irregular rhythm detection capabilities in December.



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