Marketing images of the Masimo W1 medical watch.
The Masimo W1 medical watch [Image courtesy of Masimo]



has received FDA 510(k) clearance for its medical watch for both over-the-counter and prescription use. 

The FDA clearance is the latest good news for Masimo, which has been making headway in its patent battle with tech giant Apple.  MASI shares were up more than 1% to $94.75 apiece by midday trading today on the news, which came out on the evening of Friday, Nov. 17. MassDevice‘s MedTech 100 Index is up slightly.

According to the company, the Masimo W1 is the first FDA-cleared watch capable of continuously monitoring real-time oxygen saturation (SpO2) and pulse rate for both general and medical use. The FDA’s clearance enables people to use the watch in hospitals, clinics, long-term care facilities, at home, and more.

“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,” Masimo CEO Joe Kiani said in a news release.

“We are excited about the hospital-to-home innovations the Masimo W1 can bring to the U.S, with this FDA clearance, and the empowerment of patients at home.”

The Masimo W1’s capabilities come from its integrated Masimo MW-1 sensor, hardware, and software module — which incorporates over 30 years of Signal Extraction Technology pulse oximetry knowledge into a single wearable module. The W1 has an integrated optical sensor and electrocardiogram (ECG) electrode pads that detect physiological signals.

The MW-1 module processes the signals using the company’s proprietary signal processing algorithms to output high-resolution SpO2, pulse rate, perfusion index (Pi), and heart rate (HR) from an ECG.

Continuous pulse oximetry data, under the care of a physician, can give greater visibility to changes in oxygen saturation to help patients better manage their oxygen levels daily, according to Masimo. Company officials envision health providers prescribing the watch for recovery after surgery, managing chronic breathing conditions such as COPD, and for patients with congenital heart failure.

Data collected by the MW-1 sensor is displayed in real-time on the W1’s touchscreen, with abnormal SpO2 and pulse rate values highlighted in red to aid in quickly identifying potential issues.

The Masimo W1 and the integrated Masimo MW-1 module can also provide spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.