Masimo reels in FDA nod for pulse oximetry smartwatch amid Apple Watch patent spats

About a year after beginning its full market launch, Masimo’s W1 smartwatch can now be used as a medical device in the U.S.

The wearable device has earned FDA clearance for its medical applications, Masimo announced this week. The regulatory nod allows the smartwatch to be used as a remote patient monitoring device, constantly tracking oxygen saturation levels and pulse rates for wearers whether they’re in hospitals, long-term care facilities or their own homes.

Those round-the-clock data points are especially important when it comes to monitoring the health of people who are recovering from surgery or have been diagnosed with a condition like chronic obstructive pulmonary disease or congenital heart failure.

The W1 wearable is powered by Masimo’s signature Signal Extraction Technology (SET) pulse oximetry technology, which has been incorporated into the MW-1 sensor, hardware and software module that are embedded into the smartwatch.

The MW-1 technology takes in physiological data collected by the device’s optical sensor and ECG electrode pads, then uses algorithms to churn out continuous SpO2, pulse rate, perfusion index and heart rate readings. The real-time results are displayed on the smartwatch’s screen, and any readings that fall outside normal ranges are shown in red text.

The FDA clearance allows the W1 wearable to be sold for both over-the-counter and prescription use—making it the first SpO2-tracking smartwatch to carry both indications in the U.S., per Masimo.

Ahead of last year’s market launch, the W1 device had already earned sign-offs in Europe and Saudi Arabia, according to the company’s announcement at the time.

“Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways,” Masimo founder and CEO Joe Kiani said in this week’s release.

“For example, Cambridge University Hospitals in England is using it to expand their Virtual Health program to support more confident patient discharge,” he said. “The Department of Anesthesiology at CHUV in Lausanne, Switzerland is using Masimo W1 on preoperative patients, to help anesthesiologists better understand the physiology and areas to improve for each patient they care for in the hospital, prior to surgery."

The FDA clearance comes as Masimo continues to duke it out with Apple in the courts over perceived overlaps between their health-tracking smartwatches.

Multiple lawsuits are currently in the works, with the duo lobbing accusations of patent infringement and trade secret theft back and forth. In one of those many cases, Masimo recently chalked up a major win as the U.S. International Trade Commission ruled last month that the Apple Watch’s built-in pulse oximeter rips off Masimo’s flagship light-based pulse ox technology. The ruling now goes to President Joe Biden, who has until late December to decide whether to allow the ITC’s proposed sales and manufacturing ban on SpO2-measuring Apple Watches to be enacted.

For its part, following the ITC’s decision, Apple argued that Masimo had started the patent battle just to make room for its own W1 smartwatch—which, the tech giant alleges, looks and acts quite a bit like the Apple Watch. Indeed, it has taken those allegations to the courts as well, in still-ongoing patent infringement filings accusing the W1 of borrowing from the Apple Watch’s outer design and inner functions.