Apple to pause US sales of smartwatches with pulse oximetry

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Dive Brief:

  • Apple will pause selling models of the Apple Watch in the U.S. that have blood oxygen monitoring functions, beginning this week, the company told the website 9to5Mac.
  • The move comes nearly two months after the U.S. International Trade Commission (USITC) ordered Apple to stop importing and selling its watches with the pulse oximetry feature in response to a patent infringement complaint brought by patient monitoring company Masimo.
  • Apple, in a statement carried by 9to5Mac, said that it was “preemptively” taking steps to comply with the USITC ruling while it awaits the outcome of a presidential review of the order. The time period for President Joe Biden to review the decision is set to expire on Dec. 25.

Dive Insight:

Masimo, which sells a competing medical watch, accused the tech giant of stealing its trade secrets and incorporating its patented technology for measuring blood oxygen saturation into some Apple Watch models.

The company filed a complaint with the USITC, which ultimately agreed, after an investigation that began in August 2021. The commission issued a final determination in October that becomes effective following a 60-day presidential review period, if the Biden administration does not veto the ruling.

“After a thorough multi-year legal investigation, the ITC found that Apple infringed certain of Masimo’s patented innovations for measuring blood oxygen,” a Masimo spokesperson said in an emailed statement to MedTech Dive. “The ITC’s expert judgment in this matter should be respected, protecting intellectual property rights and maintaining public trust in the United States’ patent system and encouraging US industry.”

BTIG analyst Marie Thibault said the most likely outcome is that the administration takes no action to prevent the trade commission’s exclusion order from going into effect.

“If the review period ends without any presidential action, then the orders would go into effect immediately. We think there remains potential for [Masimo] to secure settlements, royalty payments, or other monetary-based agreements,” Thibault wrote in a note to clients.

Apple, in its statement to 9to5Mac, said it “strongly disagrees with the order” and is pursuing a range of legal and technical options to ensure that the Apple Watch is available to customers. “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,” the company was quoted as saying.

The models affected are the Apple Watch Series 9 and Apple Watch Ultra 2. The watches will no longer be available to order from Apple’s website in the U.S. after 3 p.m. ET on Dec. 21, and inventory will no longer be available at Apple retail locations after Dec. 24, the article said.

The Apple Watch SE, which does not include the blood oxygen sensor, remains available for sale.

Masimo CEO Joe Kiani, on an earnings call last month, hailed the trade commission’s decision as a “landmark” victory and said the company will either gain a monopoly in the market or reach a settlement with Apple.

The two companies have also sued each other in federal court. A lawsuit brought by Masimo in California federal court ended in a mistrial in May, while Apple has sued Masimo for patent infringement in Delaware.