USA: You can no longer buy Apple Watch Series 9 or Ultra 2 directly from Apple – either in-store or online. Nor will Apple repair out-of-warranty Watch models from 2020 onwards ie Watch 6, 7, 8 and Ultra.
Edit: As of 27 Dec 2023, Apple’s appeal has successfully delayed the ban until January 10th, arguing that a software tweak resolves the issue. The US government will decide if this ends the matter on 12 January,
Apple stops US Watch Sales and out-of-warranty repairs on most new models.
Apple has stopped selling its latest smartwatches in its US stores and online. The decision impacts the Series 9 and Ultra 2 models and is a response to a ruling by the US International Trade Commission (ITC) in October to ban the import of these devices. The ITC ruling came after a US judge found that a key feature of Apple’s watches, the blood oxygen (SpO2) sensor, violated patents owned by a medical device company called Masimo. Furthermore, President Biden has declined to overturn the ruling.
“After careful consultations, Ambassador Katherine Tai decided not to reverse the ITC’s determination”, [ITC Determination]
The cessation of sales and out-of-warranty repairs is a proactive measure while Apple appeals the ITC’s determination. Should Apple win the appeal, sales and repairs will return to normal.
Watches are still available from other US retailers, but imports will be discontinued while supplies last.
Sales in other countries are unaffected by the ITC ruling. If Apple’s appeals fail, Apple might update the Watch’s software to remove the contested blood oxygen feature and then resume sales. However, if Apple were to do that it would also need to compensate customers who paid for the SpO2 feature, perhaps even offer to take the Watch back for a full refund. That would be a highly complex and expensive process and is the reason why Apple will settle with Massimo. Even if Apple did disable the SpO2 feature, compensation would be due to Massimo, albeit less than the cost of licencing the patent.
Apple is also facing legal challenges over smartwatch patents from another medical device company, AliveCor.
Here is what will happen
Option 1: Apple wins the legal appeal – everything is back to normal
Option 2: Apple loses the legal appeal – Apple will settle with Massimo and resume normal business. Apple will not disable SpO2 with software tweaks.
Option 3: Apple loses the legal appeal. Watch 10 (September 2024) – It is less likely to have the current SpO2 sensor that infringes on Massimo’s patent as it would require royalty payments. So it will either use the older Watch SE sensor without SpO2 or use next-generation tech (which wasn’t expected until 2025)
Although Apple is a global leader in smartwatches, with a 45% market share by some measures, the company faces challenges. To keep consumer interest, it has been boosting its smartwatches with new health monitoring features annually. With the smartphone market declining, Apple’s strategy focuses on selling accessories like the Apple Watch and AirPods to loyal iPhone users.
Apple’s upcoming release of the Vision Pro mixed reality headset is expected to make a significant marketing impact in the wearable tech product category in the coming year however, it will add very little, if anything, to the bottom line – it is a product that will set the ground rules and make a statement…not make a profit. As partial evidence, it is interesting to see that the existing gesture controls for Watch 9 and Vision Pro are the same, and we expect the same from new gesture controls.
Take Out
We are witnessing the collision of the smartwatch and medical tech worlds. Patents originally destined for medical uses many years ago are now viable and desired on consumer smartwatches across the world. The patent lawyers love all of this, and the feeding frenzies will continue for years to come.
However, industry behemoths like Apple can make it extremely difficult for smaller companies like Massimo to defend their patents through long, expensive and distracting litigation. Smaller companies even risk having key staff poached by industry leaders and their businesses ruined. Business is not pretty sometimes.
Q: Is the Apple Watch SE or SE 2nd Generation affected?
A: No. Not at all. It does not have a SpO2 sensor
Q: Should I disable software updates on my Watch 9/Ultra 2 to ensure I keep SpO2
A: Yes, that is the prudent thing to do if you want to keep the feature. You’ll also need to do the same on your iPhone to avoid complications with its SpO2 reporting features. I think this scenario is unlikely.
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Masimo is anything but a small company. I think part of the medical world and wearable world colliding is that apple, the business world, and the public, don’t understand or have a good grip on medical device companies.
It was stated that 7/10 hospitals use Masimo pulse oximeters. I find this to be a significant underestimate. As a physician who has been around his fair share of ER’s and Hospitals, I have NEVER seen a hospital use any other brand of pulse oximetry. The Masimo brand in monitoring equipment is ubiquitous to the point that most physicians, nurses, etc, including myself, could not even name another company that produces hospital grade pulse oximetry and other monitoring equipment. I don’t even know if one exists if I am being honest.
Masimo invented modern pulse oximeters in the late 1980’s. These are life saving, essential, and irreplacable and Masimo is not going anywhere quick.
Apple pulled the same stunt with Kardia when they rolled out their EKG. The difference being, Kardia was a small start up. Apple managed to bully Kardia off their device and steal their technology. Masimo is a different league. not a start up by any stretch. They are an ethical company in the business of making gold standard medical equipment that is literally life saving. To the point, despite Masimo’s subtle entry in wearables, they are not a wearable company. their clients are primarily clinics and hospitals and no respected hospital considers apple to be in the same league. But with this, comes the ultimate confusion. Masimo CEO agreed to a settlement, which they frankly don’t need and the only reason I think they would concede this is they genuinely want to get their technology in the wearable business for of course profit, but also because this is ethically the right thing to do. They previously said they would have happily worked with Apple. Apple had the budget. This is a mind blowing embarrassment. If I were on the board of directors, I’d be screaming for Tim Cook to resign.
The bully approach didn’t work, it’s a monumental failure that is largely under recognized and under criticized but is insanely embarrassing for apple. What is the logic behind not settling now? They actually think this decision will be overturned? How can they be so incredibly dim witted and arrogant. There is 0% chance it will be overturned. It’s an obvious patent infringement. Why would they not settle and spare the embarrassment and loss of profit?
Any other CEO would resign over a cluster F like this. Instead, the articles read as if apple is the victim. Insanity. I hope they do appeal and lose again just for the repeat embarrassment. Hopefully it’ll be a lesson that they can’t go around stealing technology and bully their way through business.
Only things to take from this:
-Apple severely underestimated Masimo’s stake and position
-Apple severely overestimated their ability to overcome a very obvious patent infringement
-Apple is out of their mind arrogant to think that they can win this in an appeal. It’s drags out a huge embarrassment, loses sales, and ultimately will fail again for a second embarrassment. Literally, what are they thinking?!?
-They are damaging their reputation minute by minute in the medical community and they are outsiders who have managed to inch on the outskirts of the house of medicine, and now the medical community will turn on. the sprinklers and escort them off property is my guess. Masimo is literally in the house of medicine. Invited guests.
The last point I’d make, is apple overestimates their position in the medical world. Where no physician, hospital, or clinic would consider them to be anything but outsiders trying to inch into a very data driven field. Their business model doesn’t work well for open source.
But why would they not partner with Masimo? Claiming your pulse oximeter is Masimo technology has a ton of weight behind in the medical field. It would be an entrance into the house of medicine. It would be like Ray ban manufacturing your smart frames, Leica manufacturing your photography lens, etc. It has meaning to those in the know.
Again, my suspicion is apple is horribly misinformed, and believe they are in the world of medicine, completely delusional to the reality that they are outsiders. And they underestimate Masimo’s position as true insiders into med tech. A corroboration would have made huge waves for apple. I can only guess they didn’t understand anything about it.
yeah Massimo is a 6bn company, smallER perhaps !
I hope my article doesn’t read as if Apple is the victim…happy to change if so.
ty for the extended and informative comment
“they would have happily worked with Apple”
We don’t know anything about the conditions they would have offered, or do we?
This is entirely speculation, but I could easily imagine Masimo perceiving the watch as a standalone pulse oxymeter with some fancy extra functions. From that perspective, they would consider it a bargain offer if they licenced at something like half the price of a standalone device, perhaps suggesting that Apple made a “Masimo edition” that passed the licence fee on to the customer. But from Apple’s perspective, it’s just another health metric to dazzle people looking for an excuse to upgrade, a minor improvement that can’t shift price or margin by more than a few cents. Put in Garmin terms, from Apple’s perspective it’s more like adding yet another sports profile (“now supports stand-up paddling!”) than like turning Fenix into Descent. If Masimo offered cooperation based on a “more like Descent” assumption, it’s hardly surprising that they could not find common ground.
I generally agree with the thrust of what you are saying here. Perhaps SpO2 is a little more of a driver for sales than you give it credit for tho. I’m surprised by the number of people that seem to want ECG on Garmin, so maybe there were similar numbers who wanted SpO2 on Apple et al? despite not quite knowing why they ‘needed’ it!
You are right that we are simply speculating. The worst case is that Apple approached the initial conversations with Massimo wholly cynically with the full intent of poaching staff and stealing the technical know-how. Surely noone can condone any kind of theft? So maybe it came down, as you say, to the perceived value of the tech for licencing purposes. Like you say, it is entirely plausible that Massimo overvalued its own tech but, at the same time, Apple is highly profit driven (as should be any listed company) and would inevitably undervalue bought-in tech components. The price must have been high for Apple to devote numerous people and other resources to the R&D. SpO2 must have cost Apple millions to design and develop if you include salaries and overheads. (admittedly significantly less if you are deliberately copying something rather than inadvertently re-inventing it!)
Interesting comment, I didn’t know anything about the subject. Thanx 👍