I had no idea this was a thing. Apple Watches are “Currently Unavailable”.
Yah, pretty interesting times! Small discussion over here on it, but not a lot of chatter.
Also the guys over at ATP talked about it on Episode 566, which was a good listen. They are pretty anti-patent generally so a lot of the conversation revolves around patents.
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I listened to that conversation. They were almost totally clueless when it came to the details of the watch ban, IMO. They were correct that “Apple can solve this with money”, and that the President can veto the ban. But will he?
President Obama did veto the Samsung ban on the iPhone 4 in 2013. In that case it was a giant US company vs a giant South Korean company. This time it is a giant US company vs a small US company, in a dispute that has been going on for ten years.
Is President Biden going to intervene in this David vs Goliath battle on the side of the most valuable company in the world? Less than a week before the start of an election year?
?
As much as I like Apple, from what I’ve read they are clearly in the wrong here. Masimo invented the technology and Apple hired a lot of their staff rather than paying for use of their patents. Not good. And Masimo wins my Clever Award for using the ITC to block imports in the same way designer labels use the ITC to block imports of fakes.
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When Covid hit I started researching pulse oximeters and found Masimo listed on a US government website. It links to my iPhone and integrates with Apple Health. It cost quite a bit more than my AW SE and took a month to arrive, but it is a quality device.
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Just in case you hadn’t taken a list, their newest episode has more conversation on this as it sounds like they got a ton of feedback, a lot of which was “you didn’t actually talk about the case at hand”.
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From the “Compare Apple Watches” page, reeeeeally tiny writing at the bottom:
- Following December 24, 2023, Apple no longer sells Apple Watch units in the United States with the ability to measure blood oxygen.
I don’t really get it, I’d completely forgotten that the S9 (and earlier?) watches even did blood oxygen measurements - and I have quite severe sleep apnea…
Is this a feature worth fighting quite this hard for?
Just listened to the latest episode. IMO most of the reasons given for why patients should not exist could probably be used to argue why speed limits should not exist. I listened to that part at 2X.
As for the rest of the Masimo v. Apple section and, coincidently, Marco’s adventure 
, I say: “When you find yourself in a hole, quit digging”
I like ATP. It, like some other podcasts, reminds me of a break room conversation with co-workers. And just like those conversations with co-workers, sometimes I listen. Sometimes I learn. And sometimes I grin, get up, and walk away 
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As far as features go, if Apple is doing anything in the health space I would say “yes.”
When you go to a doctor for ANYTHING they check your pulse, your blood oxygen, and your blood pressure. To the extent those things are technologically feasible, they’re important features.
AFAIK, I’ve have never had my blood oxygen checked during a doctor visit, or my one visit to an emergency room. Just BP and pulse.
Some of the features of an Apple Watch have real value, like fall detection and EKG. The AW has FDA Class 2 approval for the EKG feature, but the blood oxygen feature isn’t FDA approved.
Currently Masimo has the only watch with FDA approval “to provide continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use”
That would shock me. The sensor goes on the end of your finger, and looks like this:
They do it every time I go to any routine doctor visit, and in my (thankfully rare) visits to the ER they leave it connected to my finger the whole time I’m there.
I’m familiar with a PO2 sensor, I own one. And I’ve worn finger tip sensors during cataract surgeries and other outpatient procedures, although I’m not aware of what they were monitoring.
But neither of the two GPs I’ve seen on a regular basis or the two specialists I saw a few years ago ever used one. Could be because none of my visits were due to a respiratory problem.
The only reason you would have your blood oxygen checked during a PCP visit would be if you had a history of pulmonary diagnoses or pulmonary symtoms…
As for “FDA Class 2 approval” - that refer to a requirement for Apple to document any adverse effects and to notify users accurately of its status. It does NOT in any way imply or cerfify that it is clinically useful.
Unless you have a known pulmonary condition, it is doubtful that the oxygen monitor would be of much use unless you are a general aviation pilot, mountain climber, or for other reasons routinely venture to altitude.
Same here. My doctors surgery uses an oximeter every time I go, no matter what I’m going for. It’s pretty much the first thing they do.
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Same for me; every annual physical includes this measure.
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An oximeter on your finger is the first part of every doctor visit? And you have no chronic lung condition?
Or might they be putting an automated blood pressure cuff on your arm which measures both pulse and blood pressure?
Several years ago Tim Cook said the Apple Watch would not become a regulated medical device. So the blood oxygen sensor, etc. in the Apple Watch is informative, but basically recreational?
Even a toothbrush is a “Class 1 510(k) exempt” FDA-regulated device.
FDA regulation of many devices simply means “does no harm” or is “equvialent” to existing devices [which in turn may simply do no harm].
Gettting FDA approval to state that a device is safe and effective for diagnosis or treatment of illness is a different situation. An Apple watch does NOT meet that criteria. Indeed many “medical devices” recmmended by your doctor or dentist do not meet that criteria either.
That said - while these very basic medical “devices” may not be marketed by their manufacturers as safe/effective for diagnosis or treatment, it is perfectly legal for your doctor to offer you the medical opinion that such a device would be helpful as part of your treatment plan. Your doctor may or may not understand the nuances of FDA regulation and may or may not have an adequate scientific foundation to make such a statement - but much of clinical medicine turns out to be anecdotal rather than scientifically based.
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Right. Blood pressure cuff for blood pressure readings, then pulse oximeter. Every single time. No chronic lung conditions here. In fact, when I had a nephrologist for a short period of time due to kidney stone follow-ups, they did it there too.
Yeah, this blew my mind when I found out how many random little things were technically regulated “medical devices”. Band-aids, feminine hygiene products, etc.