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The FDA Just Cleared an iPhone ECG Sensor That Beats the Apple Watch

posted by Fnord666 on Monday April 29 2019, @12:38PM   
from the makes-your-heart-skip-a-beat dept.

upstart writes:

Submitted via IRC for ErnestTBass

The FDA just cleared an iPhone ECG sensor that beats the Apple Watch

Apple Watch wearers and fitness enthusiasts were ecstatic when Apple Watch Series 4 came out with a built-in electrocardiogram (ECG) monitor that detects irregular heart rate. And rightfully so -- early detection of atrial fibrillation (AFib) could prevent a serious medical event.

Now, a tiny smartphone accessory from life sciences company AliveCor goes two steps further: The KardiaMobile EKG Monitor detects tachycardia (unusually high heart rate) and bradycardia (unusually low heart rate).

[...] Tachycardia and bradycardia aren't often anything to worry about -- many people experience a low heart rate during sleep and daily stress can cause a high heart rate. But sometimes, these heart arrhythmias can be indicative of severe anxiety, heart disease, thyroid conditions or other health complications.

"No other consumer ECG device in the world can tell you more about your heart than KardiaMobile," said Ira Bahr, AliveCor CEO, in a statement. "Until today, patients have been frustrated when devices label their ECG reading as 'unclassified' or 'inconclusive.'"

AliveCor's device has the potential to reduce those unclassified and inconclusive readings. However, even AliveCor points out that your KardiaMobile EKG readings shouldn't replace conversations with your doctor. Rather, you should use the KardiaMobile readings to inform those conversations.

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Original Submission

• Re:What's the error rate? Re:What's the error rate? (Score: 2) by EvilSS on Monday April 29 2019, @05:29PM (2 children)

  by EvilSS (1456) on Monday April 29 2019, @05:29PM (#836312)

  False positive and false negative for either of these conditions should be near zero. These are just measuring if your heart rate is abnormally high or low based on a per-determined limits based on clinical standards. Unless you are actively being electrocuted at the time the readings should be pretty accurate.
  
  Now if that actually means something is wrong with you, well, that's where the "talk to your doctor".

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• Re:What's the error rate? Re:What's the error rate? (Score: 2) by HiThere on Monday April 29 2019, @05:56PM (1 child)

  by HiThere (866) on Monday April 29 2019, @05:56PM (#836322) Journal

  Eehhhh.... electrical reading devices tend to have a very large error rate except when used in carefully used conditions. This is true even of professional level devices, but for "consumer grade" devices....welllll....I wasn't really exaggerating too much when I compared what a poor device might return to the "Magic Eightball". If they don't reveal the false positive and false negative expectations, then that's probably because they're nearly worthless, but the FDA doesn't make them admit that.

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  • Re:What's the error rate? (Score: 2) by EvilSS on Tuesday April 30 2019, @01:10PM

    by EvilSS (1456) on Tuesday April 30 2019, @01:10PM (#836653)

    Not in this case. An ECG expects a waveform that falls within certain parameters. It's not like the optical pulse rate meters on most devices that just looks for a pulse and are easily thrown off by all kinds thigs. The software can tell when it has good capture or when it doesn't. The pulse rate should be near perfect from the ECG. So like I said, unless there is some sort of outside interference from a competing signal that just so happens to look like an ECG (vs random noise that would screw up the waveform), there should not be any false positives or false negatives with the tachy/bradycardia results.

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