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FDA approval to market the new Apple Watch as a medical device is a huge deal.
by vedtopkar 8y ago
FDA approval to market the new Apple Watch as a medical device is a huge deal.
- wintorez 8y agoMay I ask why is it a huge deal?
- deleted 8y ago[deleted]
- mandeepj 8y agoIt is not easy to get any FDA approval. Companies go bankrupt after spending millions and still don't get approved.
- johnnyfaehell 8y agoWhen you have more money than the government that’s no so much of a problem.
- mandeepj 8y agoYes, Apple is excluded from that statement. The company which had a budget of $1 billion for their new headquarters and end up spending $5b :-)
- mpweiher 8y agoAnd have that still be a rounding error on their balance sheet. :-)
- masklinn 8y agoTechnically 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).
- tinus_hn 8y agoThe US has negative money, they are in debt. I have more money than the US.
- singularity2001 8y agoMaybe you can make an offer to buy the US with 30% of your net worth. Then resell to a hedge fond.
- tinus_hn 8y agoI 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.
- masklinn 8y agoThe 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.
- snowwrestler 8y agoThe 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.
- yostrovs 8y agoIt'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.
- o_____________o 8y agoWas 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
- deleted 8y ago[deleted]
- dominotw 8y agoDidn't theranos get FDA approval too.
- pkaye 8y agoThey have different types of approval based on the risks involved. Some are a lot easier to obtain.
- Spooky23 8y agoWith a prescription you’ll be able to use HSA/Flex Spending or insurance to buy one.
- gmailsyncer 8y agoThat's fucking brilliant. Tesla, are you listening? I want the car to be an FDA approved monitoring device.
- tfandango 8y agoIt 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"
- scarface74 8y agoWhy would an insurance company care about what you do with your HSA/Flex account. They aren't out of any money.
- 24gttghh 8y agoThe IRS might care since they are the ones who enforce the rules surrounding their use, not your insurance company...
- scarface74 8y agoI took the parent post as implying that the insurance company would try to exclude purchasing the Apple Watch.
- tfandango 8y agoSorry 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.
- apkar 8y ago"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-series-4-ekg-electrocardiogram-health-2018 https://www.theverge.com/2018/9/12/17850660/apple-watch-seri...
- joshuakcockrell 8y agoWith 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.
- dv_dt 8y agoI 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...)
- el_benhameen 8y agoYeah, 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.
- gmailsyncer 8y agoThe iWatch. Yesterday's hip fashion accessory. Tomorrow's colostomy bag.
- gmailsyncer 8y agoWould people line up to buy the Rolex Submariner FDA-approved version?
- Shivetya 8y agoI 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.
- macintux 8y agoNo, 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.
- 51Cards 8y ago
- josefresco 8y agoclearance, not approval.
- vedtopkar 8y agoYou're totally right, huge distinction. Sorry for mis-speaking!
- MrUnderhill 8y agoAnyone 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-monitor-iphone/ https://www.getqardio.com/qardiocore-wearable-ecg-ekg-monito...
- aesclepius 8y agoSounds 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.
- deleted 8y ago[deleted]
- sschueller 8y agoFDA 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 https://news.ycombinator.com/item?id=16864566
- bookofjoe 8y agoMore 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.
- pjob 8y agoHasn'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.
- ksec 8y agoSame 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.
- eyeball 8y agoI wonder if I can use my flexible spending account to buy one now.