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posted by Fnord666 on Friday December 01 2017, @10:28AM   Printer-friendly
from the in-a-heartbeat dept.

The U.S. Food and Drug Administration (FDA) has approved an EKG reader medical device accessory for the Apple Watch:

Up until now, AliveCor has used the KardiaMobile device, which was stuck to the back of your smartphone and paired with an app to detect abnormal heart rhythm and atrial fibrillation (AFib). The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watch band to do the same thing.

However, rather than needing to hold your smartphone with both hands for 30 seconds to get a reading, you can get an EKG reading continuously and discreetly just by touching the band's integrated sensor.

[...] EKGs are usually only available in offices and hospitals — and only after a life-threatening event. Having one on your wrist that you can use to check your heart and then send a readout straight to your doctor is vital to prevention of a heart attack or stroke. And, as Gundotra also points out, "It's not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play."

It's worth noting Apple could easily replicate what AliveCor is doing. It has all the right equipment within the Apple Watch and the manpower to do so. However, it doesn't seem likely Apple would want to go through the hassle of FDA approval for the Watch, which is a general purpose device used for numerous other applications besides getting your heart rate.

Also at CNET and Fast Company.

Update: Apple launched a study to look for irregular heart rhythms on the Apple Watch (just as feared)

Previously: Apple Watch Could be Used to Detect Hypertension and Sleep Apnea


Original Submission

Related Stories

Apple Watch Could be Used to Detect Hypertension and Sleep Apnea 9 comments

A study suggests that the Apple Watch could be used to detect hypertension and sleep apnea in users:

A new study out from health startup Cardiogram and the University of California San Francisco (UCSF) suggests wearables like the Apple Watch, Fitbit and others are able to accurately detect common but serious conditions like hypertension and sleep apnea.

Cardiogram and UCSF previously demonstrated the ability for the Apple Watch to detect abnormal heart rhythm with a 97 percent accuracy. This new study shows the Watch can detect sleep apnea with a 90 percent accuracy and hypertension with an 82 percent accuracy.

Sleep apnea affects an estimated 22 million adults in the U.S., with another 80 percent of cases of moderate and severe obstructive sleep apnea undiagnosed, according to the American Sleep Apnea Association. This is a serious condition where the person affected stops breathing in their sleep and can lead to death.

Another 75 million American adults have high blood pressure (hypertension), according to the Centers for Disease Control (CDC), putting them at risk for heart disease and stroke, the top causes of death in the United States.

Cardiovascular Risk Stratification Using Off-the-Shelf Wearables and a Multi-Task Deep Learning Algorithm (DOI unknown)

Previously: Apple's Watch Can Detect an Abnormal Heart Rhythm With 97% Accuracy, UCSF Study Says


Original Submission

AliveCor Sensor for Apple Watch Could Detect Dangerous Levels of Potassium in the Blood 7 comments

Apple Watch wristband sensor claims to detect potassium in your blood — without needles

The AliveCor KardiaBand, a sensor compatible with the Apple Watch, can detect dangerous levels of potassium in blood with 94 percent accuracy. Though the US Food and Drug Administration has not yet approved KardiaBand for this purpose, it's an interesting step forward considering that, right now, the condition is usually caught using invasive blood tests that use needles.

The KardiaBand by AliveCor is a sensor that snaps into a slot on the watchband. The user touches the sensor, which then takes a reading of the electrical activity of the heart, called an electrocardiogram (EKG). This reading can reveal abnormal heart rhythm and atrial fibrillation (AFib), and the sensor sends the information to an app. Yesterday, at the American College of Cardiology conference in Florida, AliveCor CEO Vic Gundotra presented research done with the Mayo Clinic showing that the same technology can detect too-high levels of potassium in the blood, called hyperkalemia. Hyperkalemia can be caused by, among other things, diabetes, dehydration, and chronic kidney disease. It can lead to kidney and heart failure and in general doesn't cause obvious symptoms — meaning you could have the condition and not know it.

[...] Some previous research [DOI: 10.1016/S0196-0644(05)81476-3] [DX] has suggested that EKGs may not be a good way to diagnose hyperkalemia, but, to be fair, that research was very limited and tested two human physicians. Another study suggested that EKG readings may not be sensitive enough [open, DOI: 10.2215/​CJN.04611007] [DX] to catch everyone with hyperkalemia and that the condition doesn't always cause a different EKG reading.

Hyperkalemia.

Also at 9to5Mac.

Related: Apple's Watch Can Detect an Abnormal Heart Rhythm With 97% Accuracy, UCSF Study Says
Apple Watch Could be Used to Detect Hypertension and Sleep Apnea
FDA Approves First Medical Device Accessory for the Apple Watch


Original Submission

Apple Watch Finds a Market: Employees Who Are Not Allowed to Check their Phones 18 comments

The Apple Watch has found a surprisingly useful home

When the Apple Watch launched in 2015, it wasn't exactly clear who, or what, it was for. It was a phone accessory meant to curtail some of the notification anxiety the phones themselves had created by paring your digital life down to only the most essential disturbances. For many consumers, though, there wasn't a clear reason to keep wearing the watch after the initial sheen had worn off—unless they were fitness freaks, or overly concerned about their heart health. But a growing group of users have found them indispensable.

You might've noticed that the person who took your order at the bar, brought you the shoes you wanted to try on, or perhaps even patted you down at the airport security line, is sporting an Apple Watch, which starts at $329 for the newest Series 3 watch. And there's a pretty simple explanation: Many service-industry jobs where employees have to be on their feet all day don't allow workers to check their phones while they're on the clock. But that rule doesn't necessarily apply to a piece of unobtrusive jewelry that happens to let you text your friends and check the weather.

Quartz spoke with airline attendants, bartenders, waiters, baristas, shop owners, and (very politely) TSA employees who all said the same thing: The Apple Watch keeps them in touch when they can't be on their phones at work. Apple has increasingly been pushing the watch as a health device, and seems to have moved away from marketing it as one that offers more basic utility, as Apple continues do with the iPhone. But given that roughly 23% of the US labor force works in wholesale or retail operations, perhaps it's a market Apple should reconsider.

Related: Apple Watch Leads the Dying Smartwatch Market
FDA Approves First Medical Device Accessory for the Apple Watch
AliveCor Sensor for Apple Watch Could Detect Dangerous Levels of Potassium in the Blood
Apple Building its Own MicroLED Displays for Eventual Use in Apple Watch and Other Products


Original Submission

Apple Donates 1,000 Apple Watches to Binge Eating Study 12 comments

Apple donates 1,000 watches to eating disorder study

The use of Apple Watches in medical studies now includes research into eating disorders. Apple is donating 1,000 smartwatches to a University of North Carolina study (the Binge Eating Genetics Initiative, or BEGIN) that will help understand bulimia nervosa patients and others with binge eating behavior. The wristwear will track heart rates over a month-long period to see if there are any spikes ahead of binging incidents. If there are, it might be possible to alert caregivers and patients before these acts take place.

They either have too many unwanted smartwatches laying around, or want doctors to prescribe the Apple Watch treatment.

Also at 9to5Mac and Fast Company.

Related: Apple's Watch Can Detect an Abnormal Heart Rhythm With 97% Accuracy, UCSF Study Says
Apple Watch Could be Used to Detect Hypertension and Sleep Apnea
FDA Approves First Medical Device Accessory for the Apple Watch
AliveCor Sensor for Apple Watch Could Detect Dangerous Levels of Potassium in the Blood
What Cardiologists Think About the Apple Watch's Heart-Tracking Feature


Original Submission

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  • (Score: 2) by Rosco P. Coltrane on Friday December 01 2017, @01:18PM (2 children)

    by Rosco P. Coltrane (4757) on Friday December 01 2017, @01:18PM (#603880)

    Having of a heart attack or letting Apple collect my health data and monetize the shit out of it... Both make me equally nauseous.

    • (Score: 2) by EvilSS on Friday December 01 2017, @07:07PM (1 child)

      by EvilSS (1456) Subscriber Badge on Friday December 01 2017, @07:07PM (#604006)
      Apple doesn't collect health data. It stays on the device unless you a) manually turn on health data backup to iCloud, (it's off by default) b) back it up to your mac/PC via iTunes (requires encrypted backups be enabled), or c) give permissions to a third party application that can then export it for you. And if you give permissions to a 3rd party app that's on you

      Now what the AliveCor app does with the data (that you have to manually allow them access to) is another question entirely.
      • (Score: 0) by Anonymous Coward on Saturday December 02 2017, @01:15AM

        by Anonymous Coward on Saturday December 02 2017, @01:15AM (#604121)

        The real problem is that this garbage is proprietary. In that case, who knows what it sends, or if it does.

  • (Score: 3, Informative) by All Your Lawn Are Belong To Us on Friday December 01 2017, @03:57PM

    by All Your Lawn Are Belong To Us (6553) on Friday December 01 2017, @03:57PM (#603940) Journal

    Except that this is something less than even a four lead ECG monitor. It's a two point of contact monitor (single lead), which has incredibly limited utility for diagnosing anything. It may help indicate to a doctor you have AFib, and it would show other gross anomalies that you'd be calling an ambulance for already due to symptoms. And guess what your doctor will do even if it provides a textbook-perfect recording? Order a twelve-lead ECG and maybe a stress test, or a Holter monitor.

    You can also be experiencing AFib and be completely asymptomatic, which is why you need a constant monitor, not a "I'll check it when I feel bad" thing.

    It also seems to be (and I could be wrong on this one) a touch-the-fingers-to-it-and-it-will-record. It almost has to be that way since you need bilateralism to get anything and the watch sits on one wrist. What that means: It's not like a Holter monitor, which is continuously monitoring your heart. (By the way, things like Holter monitors rule out the claim above that you need to be in a doctor's office.)

    Also, looking at AliveCor's website and their clinical documentation... they have two presentations and a published letter to the editor of a journal. No peer reviewed studies.

    It's not a toy - FDA certification means the software is safe for the medical application applied for. But I'm wondering what precisely it's been certified to the FDA for. It's a big process but devices are usually cleared for certain procedures. So it will be interesting if clinicians (in general) actually make anything out of it, or simply keep to the established standards. In the meantime, you could get one and play doctor with yourself! :)

    --
    This sig for rent.
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