Medical technology company Masimo has received the US Food and Drug Administration (FDA) 510(k) clearance for its Masimo W1 medical watch for over-the-counter (OTC) and prescription use (Rx).

Masimo W1 is said to be the first FDA-approved watch to offer continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx usage.

The FDA clearance expands the medical watch’s indications for use by adults in hospitals, long-term care facilities, clinics, and homes in the US.

According to Masimo, the watch has been designed to be both comfortable and convenient for daily use.

It is intended to offer users untethered continuous pulse oximetry to make people stay active wherever they go.

Masimo founder and CEO Joe Kiani said: “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 programme 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.”

The Masimo W1 incorporates a Masimo MW-1 sensor, hardware, and software module.

The medical technology company said that the device can identify physiological signs using its built-in optical sensor and electrode pads for an electrocardiogram (ECG).

Additionally, the Masimo MW-1 module uses its in-house signal processing algorithms to interpret these signals and generate high-resolution ECG data for SpO2, PR, Pi, and heart rate (HR).

Under a doctor’s supervision, continuous pulse oximetry data can provide more visibility into variations in oxygen saturation, enabling patients to more effectively regulate their oxygen levels daily, Masimo added.

The Masimo W1 watch touchscreen displays the continuous data from the Masimo MW-1 module in an easily comprehensible way in real-time.

In addition, the Masimo W1 and integrated Masimo MW-1 module are designed for spot-checking arterial haemoglobin functional SpO2 and PR.