Apple is facing one of the most consequential days yet in its long-running health‑tech battle with Masimo. A federal jury in California has ordered the iPhone maker to pay $634 million for infringing a Masimo patent tied to blood‑oxygen monitoring in the Apple Watch, even as the U.S. International Trade Commission (ITC) launches a fresh inquiry into Apple’s redesigned blood oxygen feature — potentially putting new Apple Watch models at risk of another import ban. [1]
Key takeaways
- Jury awards Masimo $634 million after finding that Apple Watch features, including workout mode and high‑heart‑rate notifications, infringe a Masimo blood‑oxygen patent. [2]
- Jurors agreed certain Apple Watch models qualify as “patient monitors,” a pivotal legal finding that helped unlock hundreds of millions in damages. [3]
- The ITC has opened a new proceeding to decide whether Apple’s redesigned blood oxygen implementation still violates Masimo’s patents and should again trigger an import ban. [4]
- Apple says it will appeal the verdict and calls Masimo’s ITC push a misuse of the trade tribunal’s powers, arguing Masimo has “no meaningful domestic industry” that needs protection. [5]
- Masimo is simultaneously suing U.S. Customs over its decision to let Apple’s workaround back into the country, while Apple presses a separate appeal challenging the original ITC ban. [6]
Inside the $634 million Apple Watch verdict
On Friday, November 14, 2025, a federal jury in Santa Ana, California, ruled that Apple must pay Masimo $634 million for infringing a patent that covers aspects of light‑based pulse‑oximetry — the technology used to estimate blood‑oxygen levels — in certain Apple Watch models. [7]
According to detailed trial coverage from the Daily Journal, jurors found that all four asserted claims of Masimo’s pulse‑oximetry patent were infringed and that the accused Apple Watch models legally qualify as “patient monitors” under the patent’s language. [8]
The “patient monitor” question that changed everything
Much of the trial turned on an unassuming phrase in Masimo’s patent: “patient monitor.” Apple argued that a patient monitor is a clinical‑grade device — something used in hospitals that must track vital signs continuously and cannot miss critical medical events. Its lawyers told jurors that a smartwatch designed for everyday consumers, which only sends certain alerts and depends on user behavior, doesn’t fit that definition. [9]
Masimo countered that the Apple Watch is, in effect, a patient monitor because:
- Apple’s own documents describe the watch as one of the most widely used heart‑rate monitors in the world.
- Physicians and patients routinely rely on its readings in real‑world care.
- The watch is designed to detect a physiological event — such as an elevated heart rate at rest — with high sensitivity, which Masimo said satisfied the patent’s requirements. [10]
Jurors sided with Masimo on that issue, accepting that the Apple Watch can be a patient‑monitoring device for purposes of patent law. That interpretation opened the door to damages on tens of millions of devices.
How jurors got to $634 million
Masimo told the jury that Apple incorporated its patented pulse‑oximetry technology into roughly 43 million Apple Watches sold between 2020 and 2022, and asked for royalties in the range of $634 million to $749 million. Apple urged jurors to award no more than $3 million to $6 million total. [11]
The panel ultimately delivered $634 million — near the low end of Masimo’s ask, but still one of the largest patent awards ever seen in the Central District of California in a consumer‑tech case. [12]
Apple and Masimo react
In a statement reported by Reuters, Apple said it disagrees with the verdict and will appeal, signaling post‑trial motions and a likely trip to the U.S. Court of Appeals for the Federal Circuit. Masimo called the outcome “a significant win” for its efforts to protect its intellectual property and innovations in medical monitoring. [13]
The verdict does not immediately force Apple to pull products from shelves, but it sharply raises the financial and legal pressure on the company as regulators simultaneously revisit its workaround blood oxygen feature.
ITC reopens probe into Apple’s redesigned Blood Oxygen feature
While the jury in Santa Ana was reaching its decision, the U.S. International Trade Commission — the trade tribunal that can ban imported products — was moving on a parallel track.
On Friday, the ITC said it would “institute a combined modification and enforcement proceeding” to decide whether Apple’s redesigned blood oxygen functionality complies with, or still violates, the earlier Apple Watch import ban that stemmed from Masimo’s patents. [14]
Why the new investigation matters
- In 2023, the ITC found that Apple’s prior blood‑oxygen implementation infringed Masimo’s patents and blocked imports of certain Apple Watch models, including Series 9 and Ultra 2. [15]
- To keep watches on U.S. shelves, Apple disabled blood‑oxygen readings in new inventory and devices entering the country. [16]
- In August 2025, after working with U.S. Customs and Border Protection, Apple reintroduced a “redesigned” Blood Oxygen feature, which Customs concluded did not fall within the scope of the ITC’s original order. [17]
Masimo argues Apple’s changes are cosmetic, not fundamental, and that the workaround still practices its patents. The ITC agreed that “conditions have changed” because Apple is now selling a redesigned watch that wasn’t part of the earlier investigation — and says whether this setup is allowed under the old ban is now the sole issue in the new proceeding. [18]
The commission has set a target of finishing the investigation within six months, meaning a decision could arrive by around April 2026. [19]
How Apple’s workaround actually works
As 9to5Mac and others have reported, Apple’s new approach splits the feature between watch and phone: [20]
- You initiate a Blood Oxygen session on the Apple Watch, which still uses its onboard sensors to collect data.
- Instead of showing the saturation reading on your wrist, the results appear only in the Health app on a paired iPhone, under the Respiratory section.
The ITC is now examining not just what the Apple Watch does alone, but what happens when the watch and iPhone work together — in other words, whether the combined system still performs the patented method.
Apple’s counterattack: “No domestic industry” and a rival that copies the Watch
In its recent ITC filings, Apple has gone on offense. It argues that Masimo is leveraging the trade tribunal to strong‑arm a powerful competitor, not to protect a genuine domestic product. [21]
Among Apple’s points, according to 9to5Mac’s review of the filings: [22]
- Masimo’s asserted domestic product, the Masimo W1 watch, has not been sold in more than “de minimis” quantities, even years after the original investigation.
- Masimo no longer sells any version of the W1 directly to consumers.
- A 2024 jury found that Masimo’s W1 and Freedom smartwatches willfully infringed Apple’s design patents, and the W1 is now off the market.
Apple contends that Masimo is trying to exclude “important consumer products” from the U.S. while lacking a meaningful competing product, and accuses the company of abusing the Commission’s powers to “protect” what it says is a nonexistent domestic industry. [23]
Masimo, for its part, has taken the unusual step of suing U.S. Customs over the agency’s decision to approve Apple’s workaround, arguing that Customs reversed a prior 2024 view that required Apple Watches to ship with blood oxygen disabled if they were to be sold in the U.S. [24]
A multi‑front, multi‑year health‑tech war
The events of this week are just the latest chapter in a dispute that began years ago.
- 2014–2016: Apple launches the Apple Watch, then steadily adds health features such as heart‑rate tracking and, later, blood‑oxygen estimation. [25]
- 2020: Masimo and its affiliate Cercacor sue Apple, accusing it of poaching key employees and misappropriating confidential pulse‑oximetry know‑how for use in the Apple Watch. [26]
- 2021–2023: Masimo files a separate complaint at the ITC, leading to a 2023 decision that certain Apple Watch models infringe Masimo’s patents and should be barred from import. [27]
- 2023: A trade‑secrets trial in California ends in a mistrial after jurors cannot reach a unanimous verdict; that case is still awaiting retrial. [28]
- 2024: Apple wins a token $250 verdict in Delaware in a countersuit accusing Masimo’s own watches of infringing Apple design patents — a technically favorable but practically tiny win. [29]
- 2025:
- July: Apple asks a federal appeals court to overturn the ITC’s import ban on its watches. [30]
- August: Apple’s redesigned blood oxygen implementation returns to the Apple Watch in the U.S. with Customs’ blessing; Masimo sues to block that approval. [31]
- November 14: The ITC opens its new enforcement‑and‑modification proceeding, and a Santa Ana jury delivers the $634 million patent verdict. [32]
Taken together, these cases underscore how high the stakes have become as consumer tech companies push into quasi‑medical territory, where design decisions can carry regulatory, legal, and clinical implications.
What this means for Apple Watch owners right now
If you already own a recent Apple Watch in the U.S., nothing changes overnight:
- Your watch will keep working. The jury verdict is a money judgment at this stage, not an injunction. Apple will almost certainly seek to stay any adverse orders while it appeals. [33]
- The redesigned Blood Oxygen feature remains available on U.S. models that support it, pending the outcome of the new ITC proceeding and the Customs case. [34]
The real risk for consumers lies several months down the road:
- If the ITC concludes that Apple’s workaround still infringes, it could again block imports of affected watch models.
- Depending on how the order is written, Apple might have to re‑disable, further redesign, or license the feature to keep devices flowing into the U.S. market.
International buyers are less directly affected because the ITC’s jurisdiction is limited to U.S. imports, though court rulings can still influence Apple’s global design choices.
What happens next for Apple and Masimo?
Here’s what to watch for in the coming months:
- Post‑trial motions & appeal in the $634M case
- Apple can ask the trial judge to reduce or overturn the damages or to order a new trial.
- If those efforts fail, the company is expected to appeal to the Federal Circuit, which has the final say on many U.S. patent disputes. [35]
- The ITC’s six‑month clock
- The ITC has publicly targeted a six‑month window to complete its combined modification and enforcement proceeding.
- That process will include fact‑finding about how Apple’s current blood oxygen implementation works and expert testimony on whether it still falls within Masimo’s patents. [36]
- Masimo’s lawsuit against U.S. Customs
- That case, focused on whether Customs lawfully cleared Apple’s workaround, could create additional constraints or clarity around how far Apple can go in tweaking a feature to sidestep an ITC order. [37]
- Settlement pressure on both sides
- A nine‑figure jury verdict, a live import‑ban threat, and dueling lawsuits on two coasts often push parties toward negotiations.
- Any settlement could involve cross‑licensing, royalty payments on future watches, or broader cooperation on medical‑grade wearables — though there is no public sign yet that either company is ready to compromise.
Why this fight matters beyond Apple and Masimo
However it ends, Masimo v. Apple is poised to shape more than one company’s product roadmap. Courts and regulators are being asked to decide:
- When does a consumer gadget become a “patient monitor”?
- How far can a company go in redesigning a feature to work around a patent or trade ruling?
- What counts as a real domestic industry deserving protection at the ITC in a world where many devices are manufactured overseas?
The jury’s embrace of the “patient monitor” label for a smartwatch, and the ITC’s willingness to re‑open a workaround designed in close consultation with regulators, sends a signal to every tech company blending wellness features with medical‑style claims. [38]
For Apple Watch owners and investors, the headline numbers — $634 million in damages and a renewed threat of an import ban — are eye‑catching. But the deeper story is about how law and technology are colliding on your wrist, and how the next generation of health wearables will be designed in response.
References
1. www.reuters.com, 2. www.reuters.com, 3. www.dailyjournal.com, 4. www.reuters.com, 5. www.reuters.com, 6. www.fiercebiotech.com, 7. www.reuters.com, 8. www.dailyjournal.com, 9. www.dailyjournal.com, 10. www.dailyjournal.com, 11. www.dailyjournal.com, 12. www.dailyjournal.com, 13. www.reuters.com, 14. www.reuters.com, 15. en.wikipedia.org, 16. www.reuters.com, 17. www.fiercebiotech.com, 18. 9to5mac.com, 19. www.reuters.com, 20. 9to5mac.com, 21. 9to5mac.com, 22. 9to5mac.com, 23. 9to5mac.com, 24. www.fiercebiotech.com, 25. en.wikipedia.org, 26. en.wikipedia.org, 27. en.wikipedia.org, 28. en.wikipedia.org, 29. www.reuters.com, 30. www.reuters.com, 31. www.fiercebiotech.com, 32. www.reuters.com, 33. www.reuters.com, 34. 9to5mac.com, 35. www.dailyjournal.com, 36. www.reuters.com, 37. www.fiercebiotech.com, 38. www.dailyjournal.com
