Masimo Nabs W1 Medical Watch Clearance After ITC Order potential ban of Apple Watch Imports

Masimo recently announced that the Masimo W1 medical watch has received FDA 510(k) clearance for both over-the-counter (OTC) and prescription use, expanding indication for the device in the United States to use by adults in hospitals, clinics, long-term care facilities, and at home.

The W1 integrates its MW1-1 sensor, hardware, and software module pulse oximetry knowledge into a single wearable. The watch includes an optical sensor and electrocardiogram electrode pads which can detect physiological signals. The MW1 processes these signals using the company’s proprietary signal processing algorithms to output “high resolution SpO2, PR, perfusion index (Pi), and heart rate from an ECG,” according to Masimo. Continuous data from the module is displayed in real-time on the watch touchscreen and helps identify low oxygen saturation, high pulse rate, or low pulse rate by showing SpO2 and PR values in red.  

“Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways,” said Joe Kiani, founder and CEO of Masimo, in the press release announcing the approval. “For example, Cambridge University Hospitals in England is using it to expand their Virtual Health program to support more confident patient discharge. 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. We are excited about the hospital-to-home innovations the Masimo W1 can bring to the US, with this FDA clearance, and the empowerment of patients at home.”

The clearance comes after the US International Trade Commission (ITC) issued an order to Apple at the end of October which could bar the tech giant from importing its Apple Watches. The decision is due to a court ruling, which was upheld at the beginning of the year, that found Apple had violated Masimo’s rights in light-based technology for reading blood-oxygen levels. Masimo alleged that the company stole its intellectual property and incorporated it in several Apple Watch models.

The decision will not go into immediate effect as it now faces presidential review and possible appeals. The Biden Administration has 60 days to decide whether to veto the import ban based on policy concerns. Of note, presidents have rarely vetoed bans in the past. Additionally, Apple has the opportunity to appeal the ban in the US Court of Appeals for the Federal Circuit after the review period ends.

Along with Apple and Masimo’s legal fight, there continues to be ongoing pushback to further inform the public of long-standing worries connected to the accuracy of pulse oximetry dependent on skin tone differences. Recently, 25 attorney generals came together in a letter to the FDA to “encourage the FDA to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin.”

They wrote that since FDA convened an advisory committee in 2022 to discuss mounting evidence from real-word studies that suggest performance of pulse oximeters can be affected by skin pigmentation, devices have continued to be sold “without clear warning labels or other guidance to protect individuals from harm.”

The letter called on the administration to immediately take six actions to ensure the safety and effectiveness of the device, MD+DI previously reported. “As you know, regulation of medical devices such as pulse oximeters, including their ‘safety and effectiveness,’ is the responsibility of the FDA 21 U.S.C. § 360k(a),” according to the letter. “We therefore respectfully ask the FDA to take immediate action to ameliorate further unnecessary health risk to people with darker skin tones.”