Apple plans to pause US smartwatch sales ahead of Biden ruling on pulse oximetry tech ban

With only a week left in the Biden administration's review of a proposed import ban on Apple Watches containing a blood oxygen sensor, Apple is preemptively complying with the sales stoppage.

The U.S. International Trade Commission levied the ban in late October, after which it was sent to Biden’s desk for a two-month review period. His administration has until Christmas Day, Dec. 25, to decide whether to let the ban stand.

The ITC came to its decision based on arguments from both Apple and Masimo, as the latter has accused the tech giant of infringing upon its patented light-based pulse oximetry technology. Apple, for its part, has denied those allegations and claimed that Masimo is only pursuing the legal challenge to clear a path for its own newly FDA-cleared health-tracking smartwatch, which Apple says bears more than a few internal and external similarities to the Apple Watch.

Despite those arguments—and even as it maintains that the ITC ruling is incorrect and should be reversed—with the potential import ban looming, Apple has opted to pause U.S. sales of its smartwatch containing the disputed blood oxygen sensor.

The company confirmed to Fierce Medtech that its Series 9 and Ultra 2 Apple Watch models will no longer be available for purchase from its website beginning the afternoon of Dec. 21, while in-store sales and the delivery of online orders will end Dec. 24. Meanwhile, the Apple Watch SE will remain available, since it does not offer the pulse oximetry feature.

The sales pause doesn’t affect previous purchases of Apple Watches with the feature, nor does it impact international sales of the devices, since the ITC’s ruling is confined to the U.S.

“Apple strongly disagrees with the order and is pursuing a range of legal and technical options to ensure that Apple Watch is available to customers,” the company said in a statement. “Should the order stand, Apple will continue to take all measures to return Apple Watch Series 9 and Apple Watch Ultra 2 to customers in the U.S. as soon as possible.”

Those measures include Apple’s plans to appeal the ITC ruling in federal court, according to the company, which also noted that the U.S. Trade Representative, Katherine Tai, could still veto the ruling in her own review.

Apple is also still pursuing a pair of patent infringement lawsuits against Masimo that it originally filed in October 2022, claiming that the medtech giant’s own smartwatch draws from some of Apple’s intellectual property.

Earlier this year, the Biden administration allowed another proposed Apple Watch import ban to stand. In that case, the ITC ruled against Apple based on AliveCor’s allegations that the ECG feature built into certain models of the Apple Watch infringed on AliveCor’s patents.

That import ban still has yet to take effect, however, since the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled around the same time that the patents at the center of AliveCor’s case are actually invalid, rendering the ITC’s ruling moot—though AliveCor subsequently moved to appeal the patent board’s decision.