Why my Apple Watch isn’t reporting blood-oxygen levels

The watch’s pulse meter could act as an early warning for COVID-19 infections, according to this article, if the FDA would give it the government’s blessing.

From James Copeland’s “Suffocating Progress” posted last week by City Journal:

Among its many features, the Apple Watch can take your pulse. It also contains hardware to measure your blood-oxygen levels, and it has been doing so since the watch was released—but the hardware is not operable by the watch’s wearer, who thus cannot obtain the results. Under current FDA regulation, the function is disabled..

This matters in the Covid pandemic. On April 20, emergency-room doctor Richard Levitan described in theNew York Times what he’d observed treating patients in Bellevue Hospital in New York. Levitan had seen many cases of “silent hypoxia,” unknown oxygen deprivation in which “patients without respiratory complaints had Covid pneumonia”—even those admitted to the hospital for non-Covid-related health concerns. By the time most patients made it to the hospital, they had “remarkably low oxygen saturations.” Levitan’s recommendation: “Widespread pulse oximetry screening [as] an early warning system.”

Pulse oximetry refers to the measuring of blood oxygenation noninvasively, by firing wavelengths of light—red and infrared—through the skin. Variations in absorption between the different wavelengths by arterial blood allow us to read oxygen saturation. That sounds high-tech, but it’s an old technology, first developed for earlobes in the 1930s; fingertip pulse oximeters were developed in Japan in the 1970s. The plethysmograph in the Apple Watch that measures pulse works essentially the same way.

Yet the Apple Watch currently on the market cannot make this feature available to the consumer. Relatively inexpensive pulse oximeters remain widely available—usually. Like other items, from toilet paper to surgical masks, they’re unlikely to be widely available in a pandemic, when everyone wants a device and public demand outpaces manufacturing and distribution capability. Delivery dates on Amazon are already backed up for weeks…

Some of Apple’s competitors have begun rolling out blood-oxygen monitor devices—such as Fitbit, which received FDA approval earlier this year. Samsung’s Galaxy phones possessed the capacity to read blood oxygen as well as pulse through its built-in Samsung Health app—until the most recent version, the S20, which suspended the function, likely due to regulatory and legal concerns. (I have an older version and have been using it to monitor my oxygen.) Apple itself has finally started to get FDA clearance for other heart-monitoring features, so approval for the blood-oxygen feature may be on the way, eventually.

My take: What are they waiting for?

8 Comments

  1. Aaron Belich said:
    Regarding your take, typically in Apple-fashion, the total package isn’t there yet. Be it a hardware / software, or additional device integration to the benefit of the ecosystem… something is waiting for the work to be done. Or there’s other products on the market that work just fine, so there’s no reason to put out a premium, Apple iteration of it.

    0
    May 7, 2020
  2. Gary Morton said:
    Having worked in the medical device industry for 25 years, I can attest that an FDA clearance or some type of agreement like Apple has for the A-fib ECG function is the gold standard. It generally means the functionality truly works, but it is also tough to get. However, the FDA can also get wrapped up in their shorts about a bunch of nothing. I have no information that that is happening here, but improper or incomplete certification of one minor component supplier could derail Apple’s ability to claim safety and efficacy for the pulse-ox function. Given the current global crisis, maybe Apple should ask for an Emergency Use Authorization (EAU) or maybe they already have.

    4
    May 7, 2020
    • Gregg Thurman said:
      the FDA can also get wrapped up in their shorts about a bunch of nothing.

      Puh-leeese don’t get me started on the FDA.

      0
      May 7, 2020
  3. Peter Graff said:
    For various reasons, I have thus far resisted the urge to buy an Apple watch. Along with millions of former smokers in this country, I have COPD. I am surprised to learn that hardware enabling the wearer to monitor oxygen saturation in the blood already exists in the watch. I will instantly buy the watch if Apple can persuade FDA to approve activating this ability. I’m sure I am not alone in this.

    1
    May 7, 2020
    • Bart Yee said:
      I hope you will not have to wait till September or October’s product announcements but whenever they occur and the Pulse Ox gets approved, it will be a mad dash, especially if there is an integrated Covid tracking app incorporating it and more. I suspect the aggregated health data could be staggering and informative.

      1
      May 8, 2020
  4. Fred Stein said:
    We can buy pulse oximeters on-line for about $20. They’re not so great, not medical devices. I bought one for one simple reason: Timeliness matters more than accuracy. Ditto for fall detectors in the case of a stroke. Ditto for ECGs.

    Back to the blood oxygen feature: Ventilators are brutal and can create other problems like bacterial pneumonia. Often with Covid-19, by the time patients get on the ventilators, it’s too late – grim truth. Earlier detection would allow better, safer treatments.

    5
    May 7, 2020
    • Bart Yee said:
      Agree. We use a fingertip pulse ox for my daughter which also reads pulse. It’s nice but of course clunky and can’t wear it all the time. When she gets hospitalized with a respiratory infection, she’s monitored on a pulse ox and ECG. Imagine if a hospital grade functionality could be approved with an Apple Watch feeding a Bluetooth or WiFi linked monitor hooked up to a central monitoring station in the hospital.

      Maybe that’s why the FDA has been slow, medical device makers may be lobbying against it, even in the external consumer world. But no matter, there is no better and more connected alternative, it will come along with other new functions and apps.

      0
      May 8, 2020
  5. Bart Yee said:
    The oximeter function is in all Apple Watches from the beginning. I suspect whatever the holdup was from the FDA approving or Apple seeking approval has now been cleared. I firmly believe Apple has been ready with a fully integrated PulseOx app for some time, maybe now working it into a fuller Health App or Covid-19 symptom app.

    The issue is whether they would introduce it as a simple software upgrade for all Watches with the new Watch OS or only for new Apple Watch series 6 versions first. I hope it’s the former given how important it may become for all Apple Watch users and could provide significant amounts of potential study data for researchers.

    Pulse Ox data coupled with heart rate data can also help diagnose anemia, blood loss, respiratory deficit issues like COPD, long term effects of smoking, acute asthma, even epileptic seizure side effects, or provide potential emergency calls for those who acutely become hypoxic.

    3
    May 8, 2020

Leave a Reply