Sam Brusco, Associate Editor11.20.23
Masimo’s W1 medical watch has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) and prescription (Rx) use.
The company said W1 is the first FDA-cleared watch that offers continuous, real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA nod broadens its indications in the U.S. as a medical devices for adults in hospitals, clinics, long-term care facilities, and at home.
The watch’s integrated MW-1 sensor, hardware, and software module incorporates over 30 years of Masimo’s Signal Extraction Technology (SET) pulse oximetry knowledge into a single wearable module. It has an optical sensor and electrocardiogram (ECG) electrode pads that detect physiological signals. The MW-1 module processes the signals using the company’s signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and heart rate (HR) from an ECG.
Managing oxygen levels can be prescribed for recovery after surgery, managing chronic breathing conditions (e.g., COPD), and for patients with congenital heart failure (CHF).
The MW-1 module’s continuous data is shown in real time on the W1 watch touchscreen. To help identify low oxygen saturation, high pulse rate, or low pulse rate, the SpO2 and PR values are displayed in red when they fall outside normal ranges.
Masimo founder and CEO Joe Kiani told the press, “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. 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 company also began a partnership for patient monitoring technology with GE HealthCare earlier this month.
The company said W1 is the first FDA-cleared watch that offers continuous, real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA nod broadens its indications in the U.S. as a medical devices for adults in hospitals, clinics, long-term care facilities, and at home.
The watch’s integrated MW-1 sensor, hardware, and software module incorporates over 30 years of Masimo’s Signal Extraction Technology (SET) pulse oximetry knowledge into a single wearable module. It has an optical sensor and electrocardiogram (ECG) electrode pads that detect physiological signals. The MW-1 module processes the signals using the company’s signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and heart rate (HR) from an ECG.
Managing oxygen levels can be prescribed for recovery after surgery, managing chronic breathing conditions (e.g., COPD), and for patients with congenital heart failure (CHF).
The MW-1 module’s continuous data is shown in real time on the W1 watch touchscreen. To help identify low oxygen saturation, high pulse rate, or low pulse rate, the SpO2 and PR values are displayed in red when they fall outside normal ranges.
Masimo founder and CEO Joe Kiani told the press, “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. 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 company also began a partnership for patient monitoring technology with GE HealthCare earlier this month.
