If you read how Apple estimates battery life, then you'll find that they're assuming quite heavy usage. Personally, I often have about 75% battery left when I go to bed, and this includes a daily hour long outdoor run.
In short, don't hold your breath. Apple is clearly happy with the battery size-versus-capacity tradeoff.
What you're saying is EXTREMELY misleading. (a) The watch does a fine job of sleep tracking, and many people find that very useful. Sleep tracking uses very little power, specially if you put the watch into Do Not Disturb and Theater Mode when you go to sleep.
(b) So when do you charge? Charging takes little time (down to half an hour so with Series 3 and moderate usage) so it's very practical to just charge while you're showering/shaving/dressing.
@name99, I wear mine day and night. Taking a shower or two a day and having it charge while I'm getting ready is more than enough time to keep it charged.
$400 starting price now? Jesus. I'll stick to my Series 3 for now. I upgraded from the Sport "Series 0" last year, mostly for waterproofing the OG model lacked, and honestly other than ECG, there isn't enough here to justify an upgrade.
Maybe is heart conditions ran in my family, but the watch mostly serves as a messaging hub so I don't have to pull my phone out of my pocket a lot of the time. It's also handy for helping me find my phone since I naturally keep it silent almost all the time as my watch notifies me of calls and messages.
Actually it is a class II device, which is better than a class I. Class I are FDA registered/listed, class II have received FDA "clearance" and class III are FDA approved and have undergone stringent review. Don't mix the words please.
The FDA would not approve a consumer device capable of taking ECG scans if they were not very accurate. Thats extremely dangerous, and as incompetent as the government is in a lot of areas FDA testing is generally extremely safe ESPECIALLY for something that is already a known quantity such as ECG rather than new research.
It all depends on what claims Apple is making about the ECG and whether the ECG is being used to diagnose disease.
If they are marketing it as the first smartwatch with an ECG *** not for medical use *** then sure, the FDA will give them the green light to sell it. If Apple was claiming to be able to diagnose heart disease with this device, it would be classified as a medical device and subject to strict regulatory standards. To this end, I'm struck that the article describes it as "The first consumer device...", which does not suggest to me that the Apple Watch is classified as a medical device and that the FDA merely approved their inclusion of an ECG and their marketing it as a consumer device for non-medical use. I could be wrong though as I'm only going off the information that was included in this article.
Apple and the FDA have been talking for years. The president of the American Heart Association came up and talked about why this was an important development. If this didn’t really work, that would be a bad move.
It's not about not working, it's about how it is working. The Apple theater presentation is marketing and in no way indicative of an FDA approval process.
That doesn't change the fact that it is FDA 'cleared', but not FDA 'approved'. These are very specific terms in this context, not the general uses of those words.
There is a big difference between 'cleared' and 'approved'. 'Approved' devices have undergone much more stringent testing.
It’s cleared by the FDA, which basically means that it does sorta what it said it does, and won’t explode or kill you in some other way.
This is completely different from a device that is FDA approved for medical use. Those are thoroughly tested to ensure that they are accurate enough to be used in a clinical setting.
FDA Cleared: Does it take an ECG? Does it harm you?
Why are you fighting this when even the Verge issued an article explaining the deal with the FDA clearance in relation to FDA approval. These are not just contextual synonyms. It's a cool feature, it's just not medical grade.
Why are you continuing to spread FUD and citing The Verge instead of the FDA’s own perfectly comprehensible synopsis of how they classify and regulate medical devices ( https://www.fda.gov/medicaldevices/resourcesforyou... )?
It’s a cool feature that has met 100% of the FDA’s requirements for a Class II device. The requirement to pass the full FDA approval process does not distinguish whether or not a device is “medical grade” (which AFAIK is not a term defined by the FDA) , it’s simply the standard for devices that could directly harm or kill you.
It saved my life a few months ago when it said that my resting heart rate was high (120), and that I should seek medical attention. In the emergency ward, I was told that if my watch hadn’t warned me, in a couple of days I would have had a heart attack.
People think that the only sign is pain when it occurs, but that’s wrong, it builds for several days without most people feeling much of anything, and then it “suddenly” happens. The watch caught it early.
Count it on paper and you'll know that's impossible. Automatic mechanic watch, yes possible, smartwatch? With that form factor... you can win a noble prize if you can do it with kinetic and the watch is more or less same size. Even crank charger is tiring enough for charging mobile phone
That’s a pretty steep price increase! 70 dollars more for the base version and 100 dollars more for the LTE version, compared to when Apple Watch 3 launched.
I doubt they’ll move a lot at those prices, considering that in previous quarters the older, cheaper versions of Apple Watch vastly outsold Gen. 3 Watch.
Heck, even the lowly Fitbit sold more than the Apple Watch Gen. 3.
The fit bit is a pretty different market (depending on the model at least) so that doesn't surprise me. I bought a fitbit alta hr a year or so ago and wouldn't consider buying an apple watch at all due to the price being so different.
That's probably why they'll continue selling the model 3, duh.
EVERY FSCKING YEAR! Apple releases something new, and the idiot brigade complain that it costs too much, while ignoring the fact that in a year it will still be sold (and cost less), and then a year later still sold (and cost even less). It's almost like they don't actually care about reality, they just want to whine for the sake of whining...
The ECG may be FDA approves, but I doubt it’s abyehere near the same quality as a real ECG, that uses up to a dozen contact points on the arms and legs.
According to Apple: "Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram."
It doesn't have a dozen leads, but that doesn't necessarily speak to the quality of the data it produces. The simplicity of this system could potentially eliminate a fair amount of procedural error. Plus there's the advantage of being able to take a reading whenever and wherever you think you might be having an issue, without having to go into a hospital, strip down, and have a dozen electrodes taped all over your body.
First, let me be clear that I in no way doubt the intelligence of nurses.
Furthermore, the last time I was hooked up to an ECG, it was in the emergency room. Let's just say that I have a fair amount of body hair, and had recently lost several liters of fluid. There were quite a few people in the room working on me and the process did not go smoothly. At one point they thought they'd need to shave me to get the electrodes to stick and get an accurate reading, but there wasn't time for that. Basically it drove home the idea that these systems are not as foolproof as you might think in certain real-world hospital situations.
I also realize that the Apple Watch ECG would have been entirely useless in that situation. And the "procedural error" I had in mind was more to do with the correlation and interpretation of the data from the multi-lead systems anyway.
Apple's ECG app has been cleared by the FDA as a medical device. There is nothing about the app that would make it Class III or in any way eligible for the more stringent FDA approval process.
Medical device is a loose term in your context. A fitbit or a garmin is also a medical device by the same standards. Approval is not just what the device does but how well it does it. Clearance is basically not it.
My context for the term “medical device” is precisely as defined by the FDA. Neither Fitbit nor Garmin have ever received sImilar FDA clearance for a wrist-worn ECG. Approval is for Class III and certain Class II devices, but has nothing to do with separating the “men from the boys” as you keep insisting it does. It’s merely the standard for devices that could directly harm an individual. Unless you swallow the Apple Watch, or use it to display images that trigger seizures, how is it going to directly harm you?
In most ECG systems made in the last couple of years, the machine also interprets the result, and let’s the person using it know if there is a problem, and what that problem is.
That pretty much removes any chance of misreading the result.
As for “cleared by the FDA” yes, it’s been cleared by the FDA in the same way that the 19.99$ blood pressure reader at Walgreens have been cleared by the FDA.
In both cases: The 19.99 blood pressure reader and the $399 Apple Watch will get real life results that vary wildly in accuracy, and for that reason shouldn’t be used instead of getting a proper blood pressure reading or ECG.
It hasn’t been approved by the FDA, like a real ECG machine for hospital use has been approved for clinical use.
As stated many times already, it can never get "approval" in the since you're using because it's not an option for a Class II device. It's just nomenclature, but the FDA refers to that as "certified." That said, the FDA doesn't fine anyone for using "approval" for Class I and II devices because it's still technically an approval to get their certification and to get their certification it has to be approved.
Being a single-lead ECG doesn't mean it's not a "real" ECG. It's simply different from a 12-lead ECG. Regardless of the anti-Apple narrative you're pushing it's still an electrocardiogram.
That's the wrong question. You are making the same stupid mistake as the people who said phones will never replace DSLRs, or MP3s will never replace CDs --- you're fantasizing that they solve the same problem.
Just like the camera you actually HAVE on you is more useful than the camera you have sitting at home, the EKG you have AVAILABLE is more useful than the EKG sitting in the hospital.
The use case for this device is not some doctor in a US hospital doing pre-heart-surgery prep; it is the person who has heart arrhythmia or some other intermittent condition that's difficult to describe to a doctor and that only presents rarely. IF, when the condition happens, you can immediately grab a snapshot via a simple EKG, you have SOMETHING useful. Yes, it's not perfect, no-ones claiming it is. But you don't need perfection for a specialist to look at a low quality EKG, rule out 7 of 8 possible explanations, and know what the appropriate diagnostic is for the eighth possibility.
No. That's the correct question. These wrist computers are making use of inaccurate sensor data to create a false sense of security/insecurity and pose as serious medical devices. They actively seek FDA tie-in of some sorts to sell more units. Precision is paramount if you want to brag that your device is life saving; an approximation is not good enough. Don't rely on your wrist computer, keep visiting your cardiologist even if the gadget tells you not to.
Why do you think real ECG machines use so many electrodes?
Why not use just two, like the Apple Watch?
Could it be, that there is a huge variety of error considering everything from individual biochemistry to the minute nature of the voltage recorded?
You sound like someone exhibiting the classic, flawed Silicon Valley mentality, not realizing that a lot of very smart people already took a crack at this.
You're dogmatically clinging to an opinion for which you have zero empirical evidence to support. I am making no claims as to the quality of the Apple Watche's ECG feature until I see some data regarding how it actually stacks up.
However, I also clearly remember a time when everyone didn't carry a camera and GPS in their pocket everywhere they went. The first cameras in phones sucked, and the GPS's were of questionable accuracy. Smartphone cameras still aren't nearly as good as a full sized DSLRs or pro gear, but for most folks, they work quite well and end up being the "best camera" because they're the one the person always has with them. Same goes for GPS navigation. Most people simply do not need a dedicated GPS, and what their phone can offer for turn-by-turn navigation is often better than what their car might have built in.
The Silicon Valley mentality is that if a lot of very smart people are all working on the same problem, it probably has merit, because the first person to come up with a successful strategy to market a solution will probably make a lot of money. Your mentality is apparently that the first smart devices weren't smart enough so we should have just stopped there?
Also, while the benefits of widespread ECG monitoring for healthy individuals may be questionable to non-existent, has the accuracy of similar, single-lead, OTC ECG systems such as AliveCor's Kardia ever been cited as being a problem? When my doctor asked me to perform at home monitoring of my blood pressure, should I have reported her for malpractice because obviously home blood pressure cuffs aren't as accurate as the one she has at her office and the data they provide is therefore useless? The ability to self-monitor can be beneficial to both patients and doctors even when it is understood that the accuracy may be less than what is achievable with vastly more expensive and specialized equipment.
In this case the FDA has decided that Apple's ECG and the algorithms their software employs are accurate enough that they can be sold over the counter, direct to consumer, without requiring review by a certified cardiologist prior to unlocking end user access to the data. id4andrei is hell bent on maligning this device before it even reaches customers and is spewing a lot of nonsense in the process. The FDA starts by classifying medical devices, and that in turn determines what degree of premarket approval is required. It does not work the other way around, and a Class III device is in no way "better" than a Class I or II device. A pacemaker is not "better" than an adhesive bandage, but clearly one deserves more stringent oversight than the other.
Approval is only required for Class III devices (those that sustain or support life, are implanted, or present potential high risk of illness or injury). Clearance via premarket notification [510(k)] is all that is necessary for most other devices. So the distinction isn't really meaningful—for any given device you need either clearance or approval, but never both.
However, the ECG feature of the Apple Watch was considered novel and thus it would be automatically rated Class III. Therefore Apple had to file a "De Novo" classification request, presumably to get a Class I rating for the Apple Watch. At which point FDA clearance, not approval, would have been the standard required.
The distinction is meaningful as only approved devices are subjected to stringent FDA testing. Clearance is an easy barrier to pass and awarded relative to other "cleared" devices already on the market, devices that you only approximately need to match.
This is very telling regarding the accuracy of the ECG feature. Let's wait and see maybe Apple would want to FDA approve their AW for the purpose of ECG, until then it is not a class III medical device.
While you are correct about the distinction between "approval" and "clearance" as far as the FDA is concerned, you're also willfully ignoring the fact that this was a De Novo request and intentionally spreading FUD. It turns out that the ECG app is what has been cleared by the FDA, and it was determined to be Class II, the same class as home blood pressure cuffs. Here is the actual FDA clearance letter: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN...
Being De Novo, there were no other comparable "cleared" devices on the market. Apple's product is the yardstick by which the FDA will now classify future devices requesting clearance.
No reasonable assessment of the risks associated with the Apple Watch ECG feature would ever place it in Class III or even Class II (Special Controls) which would merit FDA approval. The FDA would never proceed with the approval process for this type of device. You can't make a Band-Aid a Class III medical device by putting it through the FDA approval process.
Apple got it first in a smartwatch but KardiaBand(also FDA cleared) got it before that, but in an AW band, still wrist based. They do the same thing and the distinction is band vs smartwatch. Apple's coup here is relative to future smartwatches but not relative to the ECG feature. None of them are FDA approved, none of them have undergone FDA review.
A band-aid cannot be a class III medical device but at the same time FDA clearance is not an indicative of quality, reliability, accuracy. Just because Apple(and Kardiaband) got FDA clearance means nothing. It's just marketing tie-in to induce a false sense of security. I'd argue the ECG device at your local cardiologist is a proper approved medical device because FDA approval is not just associated risk, it's also a quality assurance; clearance is not.
They have undergone FDA review, which classified them as not requiring approval prior to marketing.
Mandatory performance standards are one of the special controls associated with Class II devices. Premarket approval is for Class III devices that support or sustain human life.
The FDA defines and regulates the medical devices that can be sold legally in the US. They are a federal agency. FDA clearance isn’t a “marketing tie-in”, it’s a requirement to sell a medical device in the US.
Early rumors suggested that the new watch would use the first-ever-consumer MicroLED. Did that end up happening or is this an OLED or IPS? I haven't seen much detail about the watch screen...
Apple's version of LTPO uses OLED to make the light, and LTPO as the backplane for the display electronics. This saves 5 to 15% power. It appears (as far as I can tell) to be an Apple display innovation, not a generic display innovation from someone like Samsung or LG.
(The LED in this context refers to each pixel which is an individual OLED. Some LCD screens talk about using LEDs, but they mean using (non-OLED) LEDs as the backlight, not per pixel.)
It would seem obvious to extend this to the iPhone, and I expect we will have that next year. Presumably it was considered too risky to ramp up what seems like a fairly new technology to try to cover this year's phones.
"Here the new watch allows for up to 8 complications which are at the disposal of the user"
Digital watches can't have complications. Only mechanical watches can. Complications "complicate" the movement of the watch.
This isn't a dig at the writer, but Apple for hi-jacking words that they have no business using. They make disposable disposable watches which is the anti-thesis to what horology is about. It's scummy for them to co-opt the terminology and misuse it.
Dont forget, they launched the “Apple Watch Hermes” in yet ANOTHER attempt to elevate their 300$ gadget into something it’s not: Anprestigious item of fashion and a real, luxury watch.
It’ll fail horribly of course, just like their last attempt: The 10.000$ Gold Apple Watch did.
Just FYI an Apple Watch Hermes costs $1250 to $1450, not $300. And it's not new, the same partnership existed for the Series 3. So presumably it sells well enough to make both Apple and Hermes happy...
All things considered it's probably the best way to resolve the issue that some people (at least for now) still think it's important to have a watch as a fashion item; a better solution than the previous gold and ceramic attempts. This is much like the genius of selling last years iPhones (and aWatches) as the cheap edition, rather than manufacturing a separate cheap edition; an out of the box thinking that's a lot smarter than what competitors are doing.
I think the meaning is meant to be “extra functions” but I can see what you mean.
The reason for their hijacking (as you put it) is because they’re trying to elevate their gadget into being a real watch.
It won’t work of course, the Apple Watch is a gadget and will never have the same place in our culture as a watch has.
It’s interesting that as smart as some of the people at Apple are, they don’t understand this.
They had the choice to turn their gadget into more of a real watch: I remember some of the speculation before it came out. How the Apple Watch was supposed to be upgradable by just swapping out the internals.
In the end, they chose not to go that way, mainly as an economic decision, I reckon.
Yeah, I'm guessing IdBuRnS is similarly outraged by Apple's appropriation of the words "desktop", "folder", and "trash" in macOS. Where will these frivolous analogies end? Think about the liberties Microsoft took with the "Recycle Bin"! Does this mean my new files are being constructed with post-consumer bits?
Contrast to the "new" Qualcomm Wear 3100, which throws in a low power core, but is on the same old 28nm node as the 2100 and same old Cortex A7 32 bit cores.
It's unclear. 7nm IS the obvious choice, because the obvious core (for reasons I've already given) is the A12's little core. (Likewise GPU as one of the A12's 4 GPU cores? But even that seems way over powered; so that run at 1/4 frequency, or maybe there is a natural way to split one of those GPU cores into a quarter?)
But there are other issues. Power matters more than performance, so you may want to "recompile" the core and the GPU to use low power transistors everywhere; and if you're doing that, maybe recompile to a different process? There's also the issue that it would be natural for Apple to maintain relationships with all three foundries, just to have backups in place. So eg they might fabricate the wireless chips (W1, W2, now W3) on GloFo, and the watch chips on Samsung? (W3 seems to bring BT 5 to the mix, W2 was BT 4.2, though had better WiFi than W1; All are still only 2.4GHz.)
I'd like Apple to ditch the motion sensors and the health monitoring stuff in order to make room for a larger battery. I think they'd be more useful as replacements for cheap flip phones by taking over basic calling and texting rather than doing whatever invasive health crap they're doing now. Just let me make phone calls and check my gmail from the stupid thing without carrying around a nowadays huge cellphone.
too bad it doesn't even look like a watch...its freaking rectangular. i wish they would make a actual watch but with "smart" capabilities. It can't be that hard. It would be an instabuy for me.
"It’s to be noted that the 64-bit part of the new CPU might not be as clear as one might think"
We know a lot more than this. The Watch is NOT running a 32-bit "mode", this is not a hardware issue it is a compiler issue. The compiler model is what you might call a small model rather than a large model; ILP32. Pointers are stored as 32-bit (so using less RAM), but the registers are 64 bit, the instructions are 64-bit. Just like ILP32 on x86.
Also we know that the watch is executing what Apple calls the ARM64e instruction set, which is a subset (or perhaps the whole) of ARMv8.3. The most significant aspect of this is PAC, pointer authentication. This is a way to "sign" pointers (procPtrs and return addresses) so that it's harder to overwrite them (so, for example, even if you discover a stack overflow bug, and use it to overwrite a return address, your return address will not be signed properly and so will generate a CPU exception). We know that A12 also has PAC, and iOS12 is using it; we don't know if watchOS is using it. It's possible the PAC instructions for the S4 are NOPs, and the importance of the ARM64e is in some of the other instructions offered (like NEON instructions for complex multiply, and a faster wat to test for exact conversion of an FP to int --- relevant to JS).
But an interesting consequence of the CPU being 64e is that it means (presumably) that it's NOT just a repurposed Zephyr (A10 small core) or Mistral (A11 small core). Apple likes to reuse IP a lot; so the obvious guess is that it's the A12 small core --- maybe they were confident enough in schedule that they were willing to tie the two projects together?
"What’s actually the most interesting in terms of the health monitoring capabilities of the new watch is that it actually includes for the first time ever a ECG (electrocardiogram) functionality in an over the counter consumer device."
How is that different than the Polar heart rate chest straps that athletes have been wearing for years? Unless I'm mistaken, they're both measuring electrical impulses.
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piroroadkill - Thursday, September 13, 2018 - link
Just a shame it's so ugly and has a short battery life... the latter being a problem with many smartwatches.29a - Thursday, September 13, 2018 - link
I keep mine in theater mode and it lasts for days.tipoo - Thursday, September 13, 2018 - link
I think the steel with link bracelet is gorgeous, ymmv.Elstar - Thursday, September 13, 2018 - link
If you read how Apple estimates battery life, then you'll find that they're assuming quite heavy usage. Personally, I often have about 75% battery left when I go to bed, and this includes a daily hour long outdoor run.In short, don't hold your breath. Apple is clearly happy with the battery size-versus-capacity tradeoff.
V900 - Thursday, September 13, 2018 - link
What do you mean by “short battery life”.It’s meant to last throughout the day and then be recharged at night.
Thats exactly what you’d expect from a watch: A device that you traditionally take off at night.
name99 - Thursday, September 13, 2018 - link
What you're saying is EXTREMELY misleading.(a) The watch does a fine job of sleep tracking, and many people find that very useful. Sleep tracking uses very little power, specially if you put the watch into Do Not Disturb and Theater Mode when you go to sleep.
(b) So when do you charge? Charging takes little time (down to half an hour so with Series 3 and moderate usage) so it's very practical to just charge while you're showering/shaving/dressing.
solipsism - Saturday, September 15, 2018 - link
@name99, I wear mine day and night. Taking a shower or two a day and having it charge while I'm getting ready is more than enough time to keep it charged.FreckledTrout - Thursday, September 13, 2018 - link
I never charged my watch or my pocket knife. I'm really not following this logic."Thats exactly what you’d expect from a watch: A device that you traditionally take off at night."
melgross - Thursday, September 13, 2018 - link
I think it’s beautiful, and they’ve won a number of design awards. It’s Apple, and so I expect some people to criticize just for that.Samus - Thursday, September 13, 2018 - link
$400 starting price now? Jesus. I'll stick to my Series 3 for now. I upgraded from the Sport "Series 0" last year, mostly for waterproofing the OG model lacked, and honestly other than ECG, there isn't enough here to justify an upgrade.Maybe is heart conditions ran in my family, but the watch mostly serves as a messaging hub so I don't have to pull my phone out of my pocket a lot of the time. It's also handy for helping me find my phone since I naturally keep it silent almost all the time as my watch notifies me of calls and messages.
Diji1 - Thursday, September 13, 2018 - link
>honestly other than ECG, there isn't enough here to justify an upgrade.It's going to be wildly innaccurate and therefore pointless based on previous devices (from all comers).
Happy to be proved wrong by reality.
29a - Thursday, September 13, 2018 - link
I kinda doubt the FDA would have approved it as a medical device if it was wildly inaccurate.id4andrei - Thursday, September 13, 2018 - link
It is not FDA approved, it has FDA clearance which is not the same as being approved.melgross - Thursday, September 13, 2018 - link
No. It’s FDA approved as a class 1 device.id4andrei - Thursday, September 13, 2018 - link
Actually it is a class II device, which is better than a class I. Class I are FDA registered/listed, class II have received FDA "clearance" and class III are FDA approved and have undergone stringent review. Don't mix the words please.repoman27 - Thursday, September 13, 2018 - link
There are no previous devices with ECG.V900 - Thursday, September 13, 2018 - link
There are plenty of non-watch devices for home use that can take an ECG.Though they mostly do worse than their cousin: The blood pressure measuring device for home use.
You really think nobody has ever thought of this before?
repoman27 - Thursday, September 13, 2018 - link
I assumed Diji1 was referring to wearables. Yes, I understand that ECG isn't new technology, but AFAIK we have yet to see it in a wearable.repoman27 - Thursday, September 13, 2018 - link
And apparently there are plenty of wearable ECGs. The Apple Watch Series 4 is merely the first “wrist-worn device” with an ECG feature.thesavvymage - Thursday, September 13, 2018 - link
The FDA would not approve a consumer device capable of taking ECG scans if they were not very accurate. Thats extremely dangerous, and as incompetent as the government is in a lot of areas FDA testing is generally extremely safe ESPECIALLY for something that is already a known quantity such as ECG rather than new research.3DoubleD - Thursday, September 13, 2018 - link
It all depends on what claims Apple is making about the ECG and whether the ECG is being used to diagnose disease.If they are marketing it as the first smartwatch with an ECG *** not for medical use *** then sure, the FDA will give them the green light to sell it. If Apple was claiming to be able to diagnose heart disease with this device, it would be classified as a medical device and subject to strict regulatory standards. To this end, I'm struck that the article describes it as "The first consumer device...", which does not suggest to me that the Apple Watch is classified as a medical device and that the FDA merely approved their inclusion of an ECG and their marketing it as a consumer device for non-medical use. I could be wrong though as I'm only going off the information that was included in this article.
id4andrei - Thursday, September 13, 2018 - link
You are correct. The ECG feature on the AW is FDA "cleared" and not FDA "approved". There is a major distinction between these two.melgross - Thursday, September 13, 2018 - link
Apple and the FDA have been talking for years. The president of the American Heart Association came up and talked about why this was an important development. If this didn’t really work, that would be a bad move.id4andrei - Thursday, September 13, 2018 - link
It's not about not working, it's about how it is working. The Apple theater presentation is marketing and in no way indicative of an FDA approval process.Tams80 - Monday, September 17, 2018 - link
That doesn't change the fact that it is FDA 'cleared', but not FDA 'approved'. These are very specific terms in this context, not the general uses of those words.There is a big difference between 'cleared' and 'approved'. 'Approved' devices have undergone much more stringent testing.
V900 - Thursday, September 13, 2018 - link
It’s NOT approved by the FDA.It’s cleared by the FDA, which basically means that it does sorta what it said it does, and won’t explode or kill you in some other way.
This is completely different from a device that is FDA approved for medical use. Those are thoroughly tested to ensure that they are accurate enough to be used in a clinical setting.
FDA Cleared: Does it take an ECG? Does it harm you?
FDA Approved: Does it take an acccurate ECG.
repoman27 - Thursday, September 13, 2018 - link
"Does it take an accurate ECG" is Class II (Performance Standards), which still does not require the approval process."Is it implanted or controlling a person's heart rhythm" is Class III.
melgross - Thursday, September 13, 2018 - link
You’re totally wrong. It’s an FDA approved and classified heart rate and ekg system.id4andrei - Thursday, September 13, 2018 - link
Why are you fighting this when even the Verge issued an article explaining the deal with the FDA clearance in relation to FDA approval. These are not just contextual synonyms. It's a cool feature, it's just not medical grade.repoman27 - Thursday, September 13, 2018 - link
Why are you continuing to spread FUD and citing The Verge instead of the FDA’s own perfectly comprehensible synopsis of how they classify and regulate medical devices ( https://www.fda.gov/medicaldevices/resourcesforyou... )?It’s a cool feature that has met 100% of the FDA’s requirements for a Class II device. The requirement to pass the full FDA approval process does not distinguish whether or not a device is “medical grade” (which AFAIK is not a term defined by the FDA) , it’s simply the standard for devices that could directly harm or kill you.
melgross - Thursday, September 13, 2018 - link
It saved my life a few months ago when it said that my resting heart rate was high (120), and that I should seek medical attention. In the emergency ward, I was told that if my watch hadn’t warned me, in a couple of days I would have had a heart attack.People think that the only sign is pain when it occurs, but that’s wrong, it builds for several days without most people feeling much of anything, and then it “suddenly” happens. The watch caught it early.
id4andrei - Thursday, September 13, 2018 - link
And if you had a fitbit/garmin/etc. would it not alarm you? Please, this sounds like those advertorials where AW saves the day.solipsism - Saturday, September 15, 2018 - link
Which FitBit and Garmin do you think offers the same feature?sharath.naik - Thursday, September 13, 2018 - link
When will any one use the band to store more battery/solar charging?. seems like a logical choice.0iron - Thursday, September 13, 2018 - link
Kinetic charging is more suitable for a watch than solar chargingWorldWithoutMadness - Thursday, September 13, 2018 - link
Count it on paper and you'll know that's impossible. Automatic mechanic watch, yes possible, smartwatch? With that form factor... you can win a noble prize if you can do it with kinetic and the watch is more or less same size. Even crank charger is tiring enough for charging mobile phoneV900 - Thursday, September 13, 2018 - link
Jeez, 399$ and 499$?!?That’s a pretty steep price increase! 70 dollars more for the base version and 100 dollars more for the LTE version, compared to when Apple Watch 3 launched.
I doubt they’ll move a lot at those prices, considering that in previous quarters the older, cheaper versions of Apple Watch vastly outsold Gen. 3 Watch.
Heck, even the lowly Fitbit sold more than the Apple Watch Gen. 3.
tipoo - Thursday, September 13, 2018 - link
And then look at what it is in Canada Bucks :/ingwe - Thursday, September 13, 2018 - link
The fit bit is a pretty different market (depending on the model at least) so that doesn't surprise me. I bought a fitbit alta hr a year or so ago and wouldn't consider buying an apple watch at all due to the price being so different.name99 - Thursday, September 13, 2018 - link
That's probably why they'll continue selling the model 3, duh.EVERY FSCKING YEAR! Apple releases something new, and the idiot brigade complain that it costs too much, while ignoring the fact that in a year it will still be sold (and cost less), and then a year later still sold (and cost even less).
It's almost like they don't actually care about reality, they just want to whine for the sake of whining...
V900 - Friday, September 14, 2018 - link
Or maybe, juuust maybe, it’s because Apple keeps increasing prices, despite having the best profit margins in the industry as it is.solipsism - Saturday, September 15, 2018 - link
Apple is selling more device than FitBit even with FitBit selling their dumb, fitness tracker at considerably lower prices.• http://fortune.com/2018/03/01/apple-watch-fitbit-w...
V900 - Thursday, September 13, 2018 - link
The ECG may be FDA approves, but I doubt it’s abyehere near the same quality as a real ECG, that uses up to a dozen contact points on the arms and legs.id4andrei - Thursday, September 13, 2018 - link
Actually it is not FDA approved, it is FDA cleared which is not the same thing.repoman27 - Thursday, September 13, 2018 - link
According to Apple: "Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram."It doesn't have a dozen leads, but that doesn't necessarily speak to the quality of the data it produces. The simplicity of this system could potentially eliminate a fair amount of procedural error. Plus there's the advantage of being able to take a reading whenever and wherever you think you might be having an issue, without having to go into a hospital, strip down, and have a dozen electrodes taped all over your body.
V900 - Thursday, September 13, 2018 - link
Dude, just stop right there.OF COURSE it isn’t as good as a real ECG.
There is a reason it hasn’t been FDA approved as a medical device.
And “procedural error”?!?
They have to strap on the electrodes to your hands and feet. That’s it! How dumb do you think your average hospital nurse is?
repoman27 - Thursday, September 13, 2018 - link
First, let me be clear that I in no way doubt the intelligence of nurses.Furthermore, the last time I was hooked up to an ECG, it was in the emergency room. Let's just say that I have a fair amount of body hair, and had recently lost several liters of fluid. There were quite a few people in the room working on me and the process did not go smoothly. At one point they thought they'd need to shave me to get the electrodes to stick and get an accurate reading, but there wasn't time for that. Basically it drove home the idea that these systems are not as foolproof as you might think in certain real-world hospital situations.
I also realize that the Apple Watch ECG would have been entirely useless in that situation. And the "procedural error" I had in mind was more to do with the correlation and interpretation of the data from the multi-lead systems anyway.
Apple's ECG app has been cleared by the FDA as a medical device. There is nothing about the app that would make it Class III or in any way eligible for the more stringent FDA approval process.
id4andrei - Thursday, September 13, 2018 - link
Medical device is a loose term in your context. A fitbit or a garmin is also a medical device by the same standards. Approval is not just what the device does but how well it does it. Clearance is basically not it.repoman27 - Thursday, September 13, 2018 - link
My context for the term “medical device” is precisely as defined by the FDA. Neither Fitbit nor Garmin have ever received sImilar FDA clearance for a wrist-worn ECG. Approval is for Class III and certain Class II devices, but has nothing to do with separating the “men from the boys” as you keep insisting it does. It’s merely the standard for devices that could directly harm an individual. Unless you swallow the Apple Watch, or use it to display images that trigger seizures, how is it going to directly harm you?V900 - Friday, September 14, 2018 - link
In most ECG systems made in the last couple of years, the machine also interprets the result, and let’s the person using it know if there is a problem, and what that problem is.That pretty much removes any chance of misreading the result.
As for “cleared by the FDA” yes, it’s been cleared by the FDA in the same way that the 19.99$ blood pressure reader at Walgreens have been cleared by the FDA.
In both cases: The 19.99 blood pressure reader and the $399 Apple Watch will get real life results that vary wildly in accuracy, and for that reason shouldn’t be used instead of getting a proper blood pressure reading or ECG.
It hasn’t been approved by the FDA, like a real ECG machine for hospital use has been approved for clinical use.
solipsism - Saturday, September 15, 2018 - link
As stated many times already, it can never get "approval" in the since you're using because it's not an option for a Class II device. It's just nomenclature, but the FDA refers to that as "certified." That said, the FDA doesn't fine anyone for using "approval" for Class I and II devices because it's still technically an approval to get their certification and to get their certification it has to be approved.solipsism - Saturday, September 15, 2018 - link
Being a single-lead ECG doesn't mean it's not a "real" ECG. It's simply different from a 12-lead ECG. Regardless of the anti-Apple narrative you're pushing it's still an electrocardiogram.name99 - Thursday, September 13, 2018 - link
That's the wrong question.You are making the same stupid mistake as the people who said phones will never replace DSLRs, or MP3s will never replace CDs --- you're fantasizing that they solve the same problem.
Just like the camera you actually HAVE on you is more useful than the camera you have sitting at home, the EKG you have AVAILABLE is more useful than the EKG sitting in the hospital.
The use case for this device is not some doctor in a US hospital doing pre-heart-surgery prep; it is the person who has heart arrhythmia or some other intermittent condition that's difficult to describe to a doctor and that only presents rarely. IF, when the condition happens, you can immediately grab a snapshot via a simple EKG, you have SOMETHING useful.
Yes, it's not perfect, no-ones claiming it is. But you don't need perfection for a specialist to look at a low quality EKG, rule out 7 of 8 possible explanations, and know what the appropriate diagnostic is for the eighth possibility.
id4andrei - Thursday, September 13, 2018 - link
No. That's the correct question. These wrist computers are making use of inaccurate sensor data to create a false sense of security/insecurity and pose as serious medical devices. They actively seek FDA tie-in of some sorts to sell more units. Precision is paramount if you want to brag that your device is life saving; an approximation is not good enough. Don't rely on your wrist computer, keep visiting your cardiologist even if the gadget tells you not to.repoman27 - Thursday, September 13, 2018 - link
100% FUD.V900 - Friday, September 14, 2018 - link
Nope, not FUD the man has a very good point.Why do you think real ECG machines use so many electrodes?
Why not use just two, like the Apple Watch?
Could it be, that there is a huge variety of error considering everything from individual biochemistry to the minute nature of the voltage recorded?
You sound like someone exhibiting the classic, flawed Silicon Valley mentality, not realizing that a lot of very smart people already took a crack at this.
repoman27 - Sunday, September 16, 2018 - link
You're dogmatically clinging to an opinion for which you have zero empirical evidence to support. I am making no claims as to the quality of the Apple Watche's ECG feature until I see some data regarding how it actually stacks up.However, I also clearly remember a time when everyone didn't carry a camera and GPS in their pocket everywhere they went. The first cameras in phones sucked, and the GPS's were of questionable accuracy. Smartphone cameras still aren't nearly as good as a full sized DSLRs or pro gear, but for most folks, they work quite well and end up being the "best camera" because they're the one the person always has with them. Same goes for GPS navigation. Most people simply do not need a dedicated GPS, and what their phone can offer for turn-by-turn navigation is often better than what their car might have built in.
The Silicon Valley mentality is that if a lot of very smart people are all working on the same problem, it probably has merit, because the first person to come up with a successful strategy to market a solution will probably make a lot of money. Your mentality is apparently that the first smart devices weren't smart enough so we should have just stopped there?
Also, while the benefits of widespread ECG monitoring for healthy individuals may be questionable to non-existent, has the accuracy of similar, single-lead, OTC ECG systems such as AliveCor's Kardia ever been cited as being a problem? When my doctor asked me to perform at home monitoring of my blood pressure, should I have reported her for malpractice because obviously home blood pressure cuffs aren't as accurate as the one she has at her office and the data they provide is therefore useless? The ability to self-monitor can be beneficial to both patients and doctors even when it is understood that the accuracy may be less than what is achievable with vastly more expensive and specialized equipment.
In this case the FDA has decided that Apple's ECG and the algorithms their software employs are accurate enough that they can be sold over the counter, direct to consumer, without requiring review by a certified cardiologist prior to unlocking end user access to the data. id4andrei is hell bent on maligning this device before it even reaches customers and is spewing a lot of nonsense in the process. The FDA starts by classifying medical devices, and that in turn determines what degree of premarket approval is required. It does not work the other way around, and a Class III device is in no way "better" than a Class I or II device. A pacemaker is not "better" than an adhesive bandage, but clearly one deserves more stringent oversight than the other.
id4andrei - Thursday, September 13, 2018 - link
Andrei, the ECG feature is not FDA approved but rather FDA cleared. It is not the same thing. FDA approved devices must pass rigorous FDA testing.waldo - Thursday, September 13, 2018 - link
Would love to see a link to that. I see it receiving a De Novo classification. https://www.apple.com/newsroom/2018/09/redesigned-...I don't find anything related to a separation between approval and clearance.
repoman27 - Thursday, September 13, 2018 - link
Approval is only required for Class III devices (those that sustain or support life, are implanted, or present potential high risk of illness or injury). Clearance via premarket notification [510(k)] is all that is necessary for most other devices. So the distinction isn't really meaningful—for any given device you need either clearance or approval, but never both.However, the ECG feature of the Apple Watch was considered novel and thus it would be automatically rated Class III. Therefore Apple had to file a "De Novo" classification request, presumably to get a Class I rating for the Apple Watch. At which point FDA clearance, not approval, would have been the standard required.
ingwe - Thursday, September 13, 2018 - link
Thanks for explaining this. Seems very informative.id4andrei - Thursday, September 13, 2018 - link
The distinction is meaningful as only approved devices are subjected to stringent FDA testing. Clearance is an easy barrier to pass and awarded relative to other "cleared" devices already on the market, devices that you only approximately need to match.This is very telling regarding the accuracy of the ECG feature. Let's wait and see maybe Apple would want to FDA approve their AW for the purpose of ECG, until then it is not a class III medical device.
repoman27 - Thursday, September 13, 2018 - link
While you are correct about the distinction between "approval" and "clearance" as far as the FDA is concerned, you're also willfully ignoring the fact that this was a De Novo request and intentionally spreading FUD. It turns out that the ECG app is what has been cleared by the FDA, and it was determined to be Class II, the same class as home blood pressure cuffs. Here is the actual FDA clearance letter: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN...Being De Novo, there were no other comparable "cleared" devices on the market. Apple's product is the yardstick by which the FDA will now classify future devices requesting clearance.
No reasonable assessment of the risks associated with the Apple Watch ECG feature would ever place it in Class III or even Class II (Special Controls) which would merit FDA approval. The FDA would never proceed with the approval process for this type of device. You can't make a Band-Aid a Class III medical device by putting it through the FDA approval process.
id4andrei - Thursday, September 13, 2018 - link
Apple got it first in a smartwatch but KardiaBand(also FDA cleared) got it before that, but in an AW band, still wrist based. They do the same thing and the distinction is band vs smartwatch. Apple's coup here is relative to future smartwatches but not relative to the ECG feature. None of them are FDA approved, none of them have undergone FDA review.A band-aid cannot be a class III medical device but at the same time FDA clearance is not an indicative of quality, reliability, accuracy. Just because Apple(and Kardiaband) got FDA clearance means nothing. It's just marketing tie-in to induce a false sense of security. I'd argue the ECG device at your local cardiologist is a proper approved medical device because FDA approval is not just associated risk, it's also a quality assurance; clearance is not.
repoman27 - Friday, September 14, 2018 - link
They have undergone FDA review, which classified them as not requiring approval prior to marketing.Mandatory performance standards are one of the special controls associated with Class II devices. Premarket approval is for Class III devices that support or sustain human life.
The FDA defines and regulates the medical devices that can be sold legally in the US. They are a federal agency. FDA clearance isn’t a “marketing tie-in”, it’s a requirement to sell a medical device in the US.
nathanddrews - Thursday, September 13, 2018 - link
Early rumors suggested that the new watch would use the first-ever-consumer MicroLED. Did that end up happening or is this an OLED or IPS? I haven't seen much detail about the watch screen...repoman27 - Thursday, September 13, 2018 - link
It's OLED with a Low-Temperature Polycrystalline Oxide (LTPO) backplane.V900 - Thursday, September 13, 2018 - link
Isn’t LTPO an LED technology? Or usually used with LED in any case?name99 - Thursday, September 13, 2018 - link
Apple's version of LTPO uses OLED to make the light, and LTPO as the backplane for the display electronics. This saves 5 to 15% power.It appears (as far as I can tell) to be an Apple display innovation, not a generic display innovation from someone like Samsung or LG.
http://www.freepatentsonline.com/y2017/0092196.htm...
(The LED in this context refers to each pixel which is an individual OLED.
Some LCD screens talk about using LEDs, but they mean using (non-OLED) LEDs as the backlight, not per pixel.)
It would seem obvious to extend this to the iPhone, and I expect we will have that next year. Presumably it was considered too risky to ramp up what seems like a fairly new technology to try to cover this year's phones.
MrSpadge - Thursday, September 13, 2018 - link
> Here the new watch allows for up to 8 complications which are at the disposal of the user.Ha, I've alsways wanted to spend big on getting even more complications from my devices!
IdBuRnS - Thursday, September 13, 2018 - link
"Here the new watch allows for up to 8 complications which are at the disposal of the user"Digital watches can't have complications. Only mechanical watches can. Complications "complicate" the movement of the watch.
This isn't a dig at the writer, but Apple for hi-jacking words that they have no business using. They make disposable disposable watches which is the anti-thesis to what horology is about. It's scummy for them to co-opt the terminology and misuse it.
V900 - Thursday, September 13, 2018 - link
Cheer up, friend!Dont forget, they launched the “Apple Watch Hermes” in yet ANOTHER attempt to elevate their 300$ gadget into something it’s not: Anprestigious item of fashion and a real, luxury watch.
It’ll fail horribly of course, just like their last attempt: The 10.000$ Gold Apple Watch did.
Let that be your revenge.
name99 - Thursday, September 13, 2018 - link
Just FYI an Apple Watch Hermes costs $1250 to $1450, not $300.And it's not new, the same partnership existed for the Series 3. So presumably it sells well enough to make both Apple and Hermes happy...
All things considered it's probably the best way to resolve the issue that some people (at least for now) still think it's important to have a watch as a fashion item; a better solution than the previous gold and ceramic attempts.
This is much like the genius of selling last years iPhones (and aWatches) as the cheap edition, rather than manufacturing a separate cheap edition; an out of the box thinking that's a lot smarter than what competitors are doing.
id4andrei - Thursday, September 13, 2018 - link
Smarter indeed but still deceit like V900 said.V900 - Thursday, September 13, 2018 - link
I think the meaning is meant to be “extra functions” but I can see what you mean.The reason for their hijacking (as you put it) is because they’re trying to elevate their gadget into being a real watch.
It won’t work of course, the Apple Watch is a gadget and will never have the same place in our culture as a watch has.
It’s interesting that as smart as some of the people at Apple are, they don’t understand this.
They had the choice to turn their gadget into more of a real watch: I remember some of the speculation before it came out. How the Apple Watch was supposed to be upgradable by just swapping out the internals.
In the end, they chose not to go that way, mainly as an economic decision, I reckon.
name99 - Thursday, September 13, 2018 - link
All hail the god of language and horology!repoman27 - Thursday, September 13, 2018 - link
Yeah, I'm guessing IdBuRnS is similarly outraged by Apple's appropriation of the words "desktop", "folder", and "trash" in macOS. Where will these frivolous analogies end? Think about the liberties Microsoft took with the "Recycle Bin"! Does this mean my new files are being constructed with post-consumer bits?solipsism - Saturday, September 15, 2018 - link
↑ LOL Brilliant.Tams80 - Monday, September 17, 2018 - link
It is disposable though, unlike a lot of traditional watches.tipoo - Thursday, September 13, 2018 - link
64 bit, might be 7nm too?Contrast to the "new" Qualcomm Wear 3100, which throws in a low power core, but is on the same old 28nm node as the 2100 and same old Cortex A7 32 bit cores.
V900 - Thursday, September 13, 2018 - link
Doubt it. That process is prob too expensive for Apples taste considering it’s a 400$ device and how much they like their margins.name99 - Thursday, September 13, 2018 - link
It's unclear. 7nm IS the obvious choice, because the obvious core (for reasons I've already given) is the A12's little core.(Likewise GPU as one of the A12's 4 GPU cores? But even that seems way over powered; so that run at 1/4 frequency, or maybe there is a natural way to split one of those GPU cores into a quarter?)
But there are other issues. Power matters more than performance, so you may want to "recompile" the core and the GPU to use low power transistors everywhere; and if you're doing that, maybe recompile to a different process? There's also the issue that it would be natural for Apple to maintain relationships with all three foundries, just to have backups in place. So eg they might fabricate the wireless chips (W1, W2, now W3) on GloFo, and the watch chips on Samsung?
(W3 seems to bring BT 5 to the mix, W2 was BT 4.2, though had better WiFi than W1; All are still only 2.4GHz.)
PeachNCream - Thursday, September 13, 2018 - link
I'd like Apple to ditch the motion sensors and the health monitoring stuff in order to make room for a larger battery. I think they'd be more useful as replacements for cheap flip phones by taking over basic calling and texting rather than doing whatever invasive health crap they're doing now. Just let me make phone calls and check my gmail from the stupid thing without carrying around a nowadays huge cellphone.V900 - Thursday, September 13, 2018 - link
Get an iPhone SE: Small, snappy and good battery life.Phones have gotten too big, and Apple is helping making that problem even worse.
Hxx - Thursday, September 13, 2018 - link
too bad it doesn't even look like a watch...its freaking rectangular. i wish they would make a actual watch but with "smart" capabilities. It can't be that hard. It would be an instabuy for me.V900 - Thursday, September 13, 2018 - link
As an owner of over a dozen watches through the years, Ibcan confirm that the Apple Watch does indeed look like... A watch.This is a watch with “smart” capabilities, what exactly do you have in mind.
name99 - Thursday, September 13, 2018 - link
"It’s to be noted that the 64-bit part of the new CPU might not be as clear as one might think"We know a lot more than this.
The Watch is NOT running a 32-bit "mode", this is not a hardware issue it is a compiler issue. The compiler model is what you might call a small model rather than a large model; ILP32. Pointers are stored as 32-bit (so using less RAM), but the registers are 64 bit, the instructions are 64-bit. Just like ILP32 on x86.
Also we know that the watch is executing what Apple calls the ARM64e instruction set, which is a subset (or perhaps the whole) of ARMv8.3. The most significant aspect of this is PAC, pointer authentication. This is a way to "sign" pointers (procPtrs and return addresses) so that it's harder to overwrite them (so, for example, even if you discover a stack overflow bug, and use it to overwrite a return address, your return address will not be signed properly and so will generate a CPU exception). We know that A12 also has PAC, and iOS12 is using it; we don't know if watchOS is using it. It's possible the PAC instructions for the S4 are NOPs, and the importance of the ARM64e is in some of the other instructions offered (like NEON instructions for complex multiply, and a faster wat to test for exact conversion of an FP to int --- relevant to JS).
But an interesting consequence of the CPU being 64e is that it means (presumably) that it's NOT just a repurposed Zephyr (A10 small core) or Mistral (A11 small core). Apple likes to reuse IP a lot; so the obvious guess is that it's the A12 small core --- maybe they were confident enough in schedule that they were willing to tie the two projects together?
Integr8d - Monday, September 17, 2018 - link
"What’s actually the most interesting in terms of the health monitoring capabilities of the new watch is that it actually includes for the first time ever a ECG (electrocardiogram) functionality in an over the counter consumer device."How is that different than the Polar heart rate chest straps that athletes have been wearing for years? Unless I'm mistaken, they're both measuring electrical impulses.