AliveCor's 510(k) clearances revealed: high, low heart rate indications, and standalone AI for future devices

KardiaMobile and KardiaStation warn users when detecting bradycardia and tachycardia. Meanwhile, the company has also laid the groundwork for streamlined AI updates across all of its current and upcoming products.
By Dave Muoio
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The last couple of months saw a pair of regulatory clearances from mobile ECG maker AliveCor surface on the FDA’s 510(k) premarket notification database — the first in March for something called KardiaAI, and the latter a dual-update for the company’s existing KardiaMobile and KardiaStation platforms for consumer and point-of-care use.

With AliveCor keeping mum at the time, MobiHealthNews suspected that the cryptic clearances might be paving the way for the company’s often-teased six-lead ECG device. While this is still the case for KardiaAI, it turns out that the clearances also allow AliveCor’s existing platforms to detect two new types of arrhythmias, the company announced on Tuesday.

Now, when consumers or clinicians conduct an instant analysis ECG test using AliveCor’s devices, the software will no longer surface an “unclassified” result when the reading is between 40-50 beats per minute or 100-140 beats per minute, Dr. Jacqueline Shreibati, chief medical officer at AliveCor, explained to MobiHealthNews. Rather, the former reading now generates an indication that the user is experiencing bradycardia while the latter produces a result for tachycardia.

Both of these terms may sound severe to those without a background in cardiology, but Shreibati said that her company is making it a point to inform its users that each can be regular occurrences among healthy adults.

“We were very deliberate in the definition of what these instant analyses meant,” she said. “It can be a little nuanced, but I think it’s an important point to make: generally speaking, bradycardia and tachycardia simply mean slow heart and fast heart, respectively. It just has to do with heart rate, and our definitions of bradycardia and tachycardia are much narrower and are addressing more the risk of ranges for those respective words.”

The primary goals of these new outputs is to reduce the frustration users may have when faced with an unclassified result, and to provide consumers with more information that they can discuss with their physician, Shreibati said. In particular, she said that the company has been keenly aware of the debate over whether consumer devices like the ECG-enabled Apple Watch could be raising unnecessary alarms, and designed the new feature in a way that she believes “struck the right balance of patient empowerment and appropriate risk profiles.”

“There is a push to empower patients and give them more information,” she said. “As a practicing cardiologist, one of the lures and thrills of working at a company like AliveCor is to see what patients and users can be capable of taking into their own hands.

“It’s been very exciting to see over the last five years that now atrial fibrillation is a dinner table [phrase], in no small part due to Apple and the thoughtful marketing they’ve had around that as well. People are learning to discuss these things with their friends and family as well as their physicians, and that’s exciting to see the evolution of the patient or consumer continuing to grow.”

In regard to the need for multiple 510(k) clearances, Shreibati said the company is implementing a strategic approach toward incorporating its algorithm in future products.

The March KardiaAI clearance allowed AliveCor to classify the algorithms originally housed within its hardware as their own independent medical device, which can then be more easily applied to the company’s current and future offerings, she said. Once this classification was established with the FDA, the latter clearance regarding the KardiaMobile and KardiaStation was a simple regulatory update so that the updated algorithms could be applied to the existing platforms.

“We have taken the algorithms outside of the medical device,” she said. “So, the algorithms that also include normal and atrial fibrillation, as well as bradycardia and tachycardia, now are self-standing. And they can be applied toward AliveCor-designed hardware, which includes our KardiaMobile, which includes the new online device [KardiaPro] … and it’ll also apply to future hardware coming out later this year.”

With Apple, Withings and a handful of other fitness and wellness device makers steadily making their push into consumer-grade cardiac monitoring, AliveCor is looking to differentiate itself as a more robust offering that can meet the needs of both patients and healthcare providers alike, Shreibati said. The new arrhythmia indications, software regulation submissions and the upcoming six-lead ECG are all steps toward this larger goal.

“Now and in the next upcoming months … we are seeking greater differentiation as a medical device that has high clinical validation and acceptance in the medical community. We have a six-lead wireless device coming out in the market in the next coming months that we’re really proud of and we’ve shown at a couple conferences. It’s under FDA review and we’re anticipating its release soon, but this will really be a product that facilitates monitoring and management of heart health in an incredibly new way beyond the single-lead ECG that we all know so well, but is becoming an increasingly crowded space,” she said.

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