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Comment by xkr | Hacker News Reader

It might be a dummy question, but what does FDA clearance mean exactly? Does it make the watch a medical-grade device and I can do ECG using the watch instead of going to the hospital?

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With FDA clearance you're allowed to brand and advertise your product as a "medical device". Also, without FDA approval, you have to be very careful about certain terms you use to describe your product's features. For example, without FDA approval, you cannot say your device "monitors" falls. You can only say it "tracks" falls. There are several other limitations because the FDA doesn't want you making these types of medical promises to customers unless the FDA has approved it.

Source: I worked on a fall detection app for the Apple Watch last year.

One possibility (remarked on by @Spooky23 above also) is that you may be able to use a pre-tax healthcare spending account (or similar vehicle - there are a couple) to pay for the device? Similarly, a doctor might be able to prescribe one.

I missed the part in the stream about FDA clearance, but my guess is yes, it would be some sort of medical device. However comparing the ECG functionality available for an apple to watch to even a standard portable 12-lead ECG is like comparing a slide rule to a modern GPU. It is definitely _not_ a replacement for going to the hospital, but it is a novelty and might be a good way to tell someone when they should go to the hospital to get checked out.

> it is a novelty

I'm sure those millions of people who have hospital-grade ECG machines at home have no need for this toy, but for those few who don't, it sounds like an absolute game-changer that could really save lives. The best medical device, like the best camera, is the one you actually have with you when you need it - and as someone who has occasionally worried about what feels like a weird heartbeat, I'll be buying this "novelty" instantly.

I would expect seniors to be a sizable portion of Apple Watches. Being FDA approved for tracking health would be a huge draw for this audience.

Watch Apple implement a subscription service to call emergency contacts in the event of a health event detected by the Watch.

It does this by default without a subscription service in the event of a detected fall if you do not respond to an alert within a certain amount of time.

Hope nobody falls on their watch and are uninjured but break the touch sensor, preventing them from being able to cancel the 911 call…

I would imagine you could press the digital crown to cancel as well.

It only calls 911 if it detects no movement after a fall, so it would have to be the motion sensors in the device that completely fail, not a touch sensor.

I was referring to the failure of whatever mechanism would be used to cancel an alert that appears post-fall.

My point is that there is no immediate need to cancel anything if you are moving.

You're right -- I thinking more of a clinical context, which is definitely the wrong frame for this. From what I've read online, it only seems to detect AFib, which is obviously useful since I think it's the most common abnormal rhythm. Maybe it's only able to detect AFib since it's just on the wearer's wrist? I wonder if there are plans to make little wireless sensors pads to mimic having more leads. That'd be pretty cool

AFib detection is, IIRC, available even without an explicit ECG session.

Many times you can detect Afib with just your fingers on the radial pulse, as a "regularly irregular" heartbeat, skipping every third or fourth beat.

The fact that it can pick up on A. Fibb, but likely track and save strips of SVT can at least get the user to a medical evaluation with a licensed physician. It's a big deal, as a medicine resident, this could be a game change for a large segment of the population.

One of the points they made was that people who go to the hospital reporting symptoms are not necessarily experiencing those symptoms during the visit, and collecting ECG data when people are going about their daily lives allows doctors to better diagnose heart conditions (Apple Watch ECG data is stored in PDF format in Health app).

An incredible novelty, one that I'm sure many concerned family members will pay $399 for.

One of the presenters mentioned this, but a good use of the Apple Watch ECG will be for patients to take an ECG when they feel weird or bad, and then the doctor can review when they come in.

It's not at all uncommon for patients to say things like "sometimes my heart races" or "sometimes I feel faint", but unless it happens when they're actually at the office, the doctor does not have any actual data to go off of.

> Does it make the watch a medical-grade device and I can do ECG using the watch instead of going to the hospital?

I think it's more the other way around. To the extent that it is marketed and used as a medical device, it has to be FDA approved.

That said, I don't think I'd recommend using it for an ECG instead of going to the hospital. "Approved" medical devices are not, of course, all of the same quality.

> Does it make the watch a medical-grade device and I can do ECG using the watch instead of going to the hospital?

This is what I am afraid of. People might think that buying a watch will replace visit with a cardiologist (or even using professional home holter) to make a serious ECG measurement (not 30s one, but full 24h scan).

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