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AliveCor monitor gets FDA approval to detect two more heart conditions than Apple Watch

AliveCor beat the Apple Watch to market with an iPhone-connected gadget with FDA approval to detect AFib – and has now been given clearance to report two more heart conditions to consumers.

The KardiaMobile EKG Monitor is a tiny $99 device that measures heart-rate through two finger pads, with results reported in an iPhone app. The company already had clearance to detect AFib, but has now been approved to detect two other common heart conditions …

In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus Rhythm, AliveCor, starting today, is able to detect and show ECG results for Bradycardia and Tachycardia. These instant analyses indicate arrhythmias that are not AFib and that are between 40-50 beats per minute (Bradycardia), or between 100-140 beats per minute (Tachycardia).

As with the Apple Watch sensor, the device could always detect these conditions, but wasn’t allowed to report them without FDA clearance. It previously had to label the readings ‘unclassified’ or ‘inconclusive.’

AliveCor is careful to warn that neither Bradycardia and Tachycardia are necessarily cause for alarm. Low heart rate is common when sleeping or deeply relaxed, for example, while high heart rate would naturally be expected during exercise. However, consistent unexplained readings in either range may be something that should be discussed with your doctor.

Bradycardia and tachycardia, which literally mean “slow heart” and “fast heart”, respectively, occur in nearly all adults. While the normal range of heart rate is between 50 and 100 beats per minute, there are many scenarios where the rate can be slightly out of this range. For example, the heart may slow below 50 beats per minute during sleep, and naturally, in many healthy adults and athletes. A fast heart rate may naturally occur in response to exercise, anxiety, or pain.

While Bradycardia and Tachycardia are often benign, these arrhythmias can be indicative of heart disease or other health conditions, such as thyroid disease. A slow or fast heart rate may be asymptomatic, or cause symptoms such as dizziness or shortness of breath. KardiaMobile users will now be able to detect these arrhythmias and use the insight to inform conversations with their doctor.

The Apple Watch currently takes regular readings of your heart-rate, and can display readings that sit within the Bradycardia and Tachycardia ranges, but without FDA approval Apple cannot label the rhythms.

There was some discussion about Apple’s claim that the Apple Watch was the first over-the-counter ECG device.

AliveCor takes issue with the ‘first time’ claim, noting that its KardiaBand got there first, but the technology is sufficiently different that the FDA considers it a completely new type of use.

The AliveCor KardaMobile EKG Monitor costs $99 and is compatible with all iPhones from the iPhone 5, and iPads back to the iPad Air and iPad mini 2.

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Avatar for Ben Lovejoy Ben Lovejoy

Ben Lovejoy is a British technology writer and EU Editor for 9to5Mac. He’s known for his op-eds and diary pieces, exploring his experience of Apple products over time, for a more rounded review. He also writes fiction, with two technothriller novels, a couple of SF shorts and a rom-com!

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