Hacker News Reader

Comment by vedtopkar | Hacker News Reader

FDA approval to market the new Apple Watch as a medical device is a huge deal.

More than a huge deal, simply astonishing to this retired long-time neurosurgical anesthesiologist. To have 1)shrunk the giant oscilloscope/monitor (1-1.5 cubic feet/±50 lbs.) atop my anesthesia machine AND eliminate the long tangled lead wires connecting to the never-available sticky gel pads that sometimes came loose in the middle of a sitting craniotomy, necessitating the anesthesiologist's equivalent of the death crawl under the stifling drapes without disturbing the surgeon, glued to his operating microscope in which every movement, even the slightest, appears like Mt. St. Helen's; 2)eliminated the need for an electrical outlet and extension cord; 3)included the capability to store endless ECG traces without needing paper for the oscilloscope printer, which more often than not wasn't working, and when it was only recorded on demand such that if you missed ectopic beats, you couldn't show them to a colleague in real time to get a second opinion: this is a magnificent engineering and design achievement. Using a thumb from the opposite hand to close the loop and act as the third functional lead is so sublime, I'm gobsmacked. The red ring on the crown is perfect as an accent for this function, along with its acting as a cellular capability indicator. Knowing just what this device has accomplished in the terms above, I might just get one just to marvel at the greatness of American engineering. "Designed by Apple in California" — indeed.

Hasn't this been addressed by products like AliveCor's kardia line for a while now? I'd prefer the form factor of a phone-paired device over a watch in a multi-patient environment.

Same here. I was actually surprised at how affordable it was, maybe it was harder to sell FDA and ECG to general public? I was expecting something like $599 or even $699.

To me this new Apple Watch was the star of the show.

I wonder if that ECG feature might change the market perception of the device - maybe that was the intent. With the ECG and slip and fall detection, I sort of thought it makes the Apple Watch sound like the most consumer medical alert bracelet ever.

For people with aging parents that don't really use mobile phones, I could many watches purchased as safety devices. (Though the battery life doesn't make it ideal for that...)

Yeah, agreed. I have never thought of buying an Apple Watch for myself or as a gift, but after seeing that, I would at least consider buying them for my mother and mother-in-law.

Agreed on the battery life. The concept is a good idea but my mother would never keep this charged up and on her wrist constantly enough for it to be relied upon.

That was my thought too. Hmm I wonder how bulky a battery add on to get the uptime to a week at a level of monitor-only activity might be?

The slip and fall protection is great. I had a tree branch fall a few feet from my head last weekend. Probably not big enough to have killed me, but I would have sure as hell been too concussed to figure out how to use the phone. Of course there wasn't cell service anyway, but that's a different issue.

If there was any cell signal on any technically compatible network, your emergency call would've been carried by another network.

I wonder if the new slip and fall detection works with motorcycles. There is quite a market for apps and devices to detect motorcycle accidents and notify someone in case something bad happens while your on 2 wheels. That would be a pretty good market to get into, basically for free.

I am interested in the idea of having one and using it on multiple members of the family, can it differentiate among a number of users? That would be a nice feature. Kind of how you personalize a car for multiple drivers.

No, it's very much a single-user device, still tied to an iPhone.

Fall detection, heart rate abnormality detection, wouldn't seem to be the type of things you'd want to only use for a short time each day anyway. You could presumably use the ECG feature on multiple people, however.

Would people line up to buy the Rolex Submariner FDA-approved version?

May I ask why is it a huge deal?

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 claims to customers unless the FDA has approved them.

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

With a prescription you’ll be able to use HSA/Flex Spending or insurance to buy one.

That's fucking brilliant. Tesla, are you listening? I want the car to be an FDA approved monitoring device.

It seems like that could be possible, even without a prescription. I can buy any number of non-prescription things with my HSA now. Obviously this seems a little different than say a blood glucose testing device. Next year they will probably amend it with a "*excluding Apple Watch"

Why would an insurance company care about what you do with your HSA/Flex account. They aren't out of any money.

The IRS might care since they are the ones who enforce the rules surrounding their use, not your insurance company...

I took the parent post as implying that the insurance company would try to exclude purchasing the Apple Watch.

Sorry that was not clear (and this response is late). I know my HSA admin limits use of those funds for medically approved things only. I assume based on rules that the government created. I am just speculating that they may have to start dealing with devices like this which have a dual purpose, mostly not medical.

"This feature has received clearance from the US Food and Drug Administration, meaning it can be used as a medical device — a move that is part of Apple’s increasing push to brand the watch as more than a fitness device." - https://www.theverge.com/2018/9/12/17850660/apple-watch-seri...

It is not easy to get any FDA approval. Companies go bankrupt after spending millions and still don't get approved.

It's a 510k "clearance", not an "approval". It's relatively cheap and all you have to do is show your thing (ECG in this case) is effectively the same as other similar devices (older ECGs) for medical purposes.

Was looking for this in the comments.

The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products.

> A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval

When you have more money than the government that’s no so much of a problem.

Technically Apple has more money than some governments, it's nowhere near the US Government's: Apple's entire assets could pay for under 18 months of net interest on the public debt (263bn in 2017).

The US has negative money, they are in debt. I have more money than the US.

The U.S. federal government can accumulate only debt, it cannot accumulate savings. Why? Because any surplus it generates is stored in Treasury bonds, which are also counted as debt.

Things are different for the federal government. It's an institution of last resort, so the normal ways of thinking about personal finance don't apply. It can't open a "savings account" anywhere, because every other institution on Earth is smaller and less reliable.

The US has assets to cover its debts in spades. Nobody would give them money for free if they didn't.

And the debt is owned at ~50% by the government itself or the Fed and ~20% by various non-federal investors (pensions, mutual funds, local governments, individuals) with the rest being owned by various non-US entities.

Maybe you can make an offer to buy the US with 30% of your net worth. Then resell to a hedge fond.

I don’t think I have the patience to deal with the ‘deal maker’ in chief, sorry. I’ve heard he’s got quite a lot of experience with bankruptcies though so he might have new ideas to deal with all that debt the US has been taking on lately.

Yes, Apple is excluded from that statement. The company which had a budget of $1 billion for their new headquarters and end up spending $5b :-)

And have that still be a rounding error on their balance sheet. :-)

They have different types of approval based on the risks involved. Some are a lot easier to obtain.

Didn't theranos get FDA approval too.

clearance, not approval.

You're totally right, huge distinction. Sorry for mis-speaking!

Anyone know how ECG from the watch compares to a device like the QardioCore [1] (or more traditional Holter monitor, i.e. the recorder with pads/wires all over)?

[1] https://www.getqardio.com/qardiocore-wearable-ecg-ekg-monito...

Sounds like the QardioCore has a 3 lead ECG. Couldn't find too much more on that, as their website is painful at best. Holter monitor is a 12 lead ECG but with some decreased signal fidelity. This is just a single lead monitoring for rhythm like a tele strip.

I wonder if I can use my flexible spending account to buy one now.

FDA approval doesn't hold much water anymore with things like a study of 25 people is enough to get transition contacts approved [1].

[1] https://news.ycombinator.com/item?id=16864566

Reply on news.ycombinator.com