U.S. International Federal Trade Commission reviews ban on new Apple Watch pulse oximeter
Apple Watch technology has been praised for its ability to help monitor cardiac health with electrocardiograms (ECG), detection of atrial fibrillation, hypertension, and, for a time, to monitor pulse oximetry levels. But the company has been challenged with patent infringement claims by the U.S. International Trade Commission (ITC)—on AliveCor’s ECG technology and on Masimo’s pulse oximetry technology.
The AliveCor case was resolved earlier this year, but the Masimo case is under a new review for a possible import ban on the latest Apple Watch Ultra 3, released in September.
The Masimo complaint was initiated in August 2021. In October 2023, the commission issued its final determination that Apple had violated several Masimo patents for its light-based pulse oximetry functionality, and issued a ban blocked imports of Apple's Series 9 and Ultra 2 smartwatches in 2023.
However, Apple revised its watch technology design, which prompted the Masimo complaint to be modified, so the case is now back for ITC review.
The ITC said in a Nov. 14 order it is investigating whether the new version of the Apple Watches that were redesigned and introduced in August 2025 are a move to circumvent the previous import ban issued by the commission, and if the technology still infringes on Masimo's patents.
The order calls for an expedited review of the case as early as possible, between mid-January and early May 2026.
The AliveCor case resulted in the commission finding Apple had violated one of two of its patent and order an import ban for the Apple Watch with the ECG feature in December 2022. But the ban was delayed pending a court appeal. AliveCor appealed the commission’s final determination because it wanted both of its patents covered and took its case to the U.S. Court of Appeals for the Federal Circuit.
Apple then cross-appealed.
That case was resolved in March 2025, with the Federal Circuit found all claims of the asserted patents were "unpatentable." The Federal Circuit also found the ITC's investigation and subsequent import ban were moot.”
Read more about the cardiac monitoring features of the newest Apple Watch.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]