Masimo W1 Health Watch Now FDA-Cleared for Wider Use

Masimo, headquartered in Irvine, CA, recently announced the market release of its Masimo W1 health watch, following the receipt of US Food and Drug Administration (FDA) 510(k) clearance for both over-the-counter (OTC) and prescription use (Rx).

This FDA clearance broadens the approved indications for the Masimo W1 as a medical device in the US, permitting its use by adults in hospitals, clinics, long-term care facilities and at home.

This innovative health watch delivers precise and continuous health metrics, coupled with actionable insights, from the renowned leader in hospital pulse oximetry. Drawing on Masimo’s extensive experience in developing groundbreaking noninvasive blood parameter monitoring solutions, the W1 presents a range of physiological data. For the first time, it includes the Hydration Index (Hi) alongside oxygen level (SpO2), pulse rate, pulse rate variability, heart rate, respiration rate, pleth variability index and perfusion index.

The watch is designed for consumers seeking to enhance their health and lifestyle choices, improve fitness, or monitor health data independently or with the support of friends and family.

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

“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,” added Kiani.

Regarding consumer use outside of the US, the Masimo W1 is accessible internationally for telehealth purposes. For example, the device is already being used for telehealth monitoring at the Prince Sultan Cardiac Center in Saudi Arabia.

Particularly beneficial for patients recuperating at home post-surgery or illness and those managing chronic conditions like heart failure, chronic obstructive pulmonary disease (COPD), or cancer, the W1 provides a practical and dependable remote patient monitoring and telehealth solution. It features seamless transmission of patient data by connecting wirelessly to the Masimo SafetyNet smartphone app and Masimo’s secure data cloud.

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The Technology Behind Masimo W1

The health watch is backed by over 30 years of innovation, utilizing an integrated Masimo MW-1 sensor, hardware and software module that consolidates over three decades of Signal Extraction Technology (SET) pulse oximetry expertise into a unified wearable module.

As per Masimo, Masimo SET® is the primary pulse oximetry technology used at nine of the top ten hospitals as ranked in the 2022 to 2023 US News & World Report Best Hospitals Honor Roll. Equipped with an incorporated optical sensor and electrocardiogram (ECG) electrode pads, it can detect physiological signals. The specifications include a display range of SpO2 from 0 percent to 100 percent, pulse rate of 0ms to 150ms, heart rate from 25bpm to 240bpm, pleth variability index from 0 to 100, among others — Masimo’s proprietary signal processing algorithms output these specifications with high accuracy.

Masimo’s website links all the studies related to Masimo’s technologies. Comparative studies include independent and objective studies comprising scientific and peer-reviewed journal articles and abstracts presented at scientific meetings.

Price and Availability of the Masimo W1 Watch

Masimo W1 is listed at $499.00, which includes a Masimo W1 watch module and wrist M-band, wireless charging cable, set-up instructions, free downloadable Masimo Health App and a three-year warranty.

Personal SafetyNet Service Membership is priced at $7.99 per month for basic membership and $18.99 per month for advanced membership.

Related: Fitbit Sense 2 Smartwatch with AFib Detection to Launch This Fall

Competitors of the Masimo W1 Watch

Fitbit and Apple Watch have already made their impact in the wearable health watch segment making Masimo W1 their competitor.

While Masimo has established itself as a prominent provider of pulse oximetry devices, it initially relinquished ground in the wearables sector to other companies. Its clinical backing provides an edge to Masimo W1 but its acceptance and market growth remains to be determined.

In October, the US International Trade Commission (ITC) ruled that the Apple Watch violates patents owned by Masimo. The contention centers on Masimo’s technology for light-based pulse oximetry. The specifics of the ITC’s decision, including which watch models are impacted, remain unclear. However, it’s noteworthy that the first Apple Watch incorporating blood oxygen monitoring was the Series 6, released in 2020. Masimo alleges that Apple engaged in talks with them in 2013 about a potential collaboration or acquisition, only to appropriate Masimo’s concept and subsequently hire several of Masimo’s engineers to realize this technology. Turning the tables, Apple has filed a complaint alleging that Masimo’s W1 smartwatches infringe on patents held by the Apple Watch.