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Home » FDA clears Masimo W1 medical watch for telemonitoring connectivity

FDA clears Masimo W1 medical watch for telemonitoring connectivity

August 12, 2024 By Sean Whooley

Masimo W1 medical watch connectivity telemonitoring (1)
The W1 medical watch with SafetyNet telemonitoring. [Image courtesy of Masimo]
Masimo (Nasdaq: MASI) announced today that the FDA granted 510(k) clearance for its W1 medical watch for connectivity purposes.

Clearance allows for the watch to integrate with the Masimo SafetyNet comprehensive telemonitoring system.

Last fall, the FDA cleared the W1 watch, which provides continuous oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use at home and in hospitals. This latest clearance enables accurate, reliable patient data, collected via the wrist-worn device, made available on the SafetyNet smartphone app. That enables review from remote caregivers anywhere and at any time.

W1’s capabilities come from the integrated Masimo MW-1 sensor, hardware, and software module. The watch features an integrated optical sensor and electrocardiogram (ECG) electrode pads that detect physiological signals. Masimo’s MW-1 module processes the signals using the company’s proprietary signal processing algorithms. This enables it to output high-resolution SpO2, pulse rate, perfusion index (Pi), and heart rate (HR) from an ECG.

SafetyNet, in turn, provides valuable insight into how patients’ physiological data changes as they go about their day. Clinicians in remote settings can track progress, tailor care programs and streamline workflows with reports, analytics and reliable medical data.

Masimo Founder and CEO Joe Kiani says the company has already successfully integrated W1 and SafetyNet in Europe and the Middle East.

“For the first time caregivers can get customized notifications, based on data from an unobtrusive pulse oximeter worn on the wrist of a patient or loved one, in situations where it’s logistically difficult to provide care in person,” Kiani said in a news release. “Masimo W1 Medical with Masimo SafetyNet opens up a world of possibilities for caregivers looking to improve quality of care and ultimately improve outcomes for those they care for.”

Filed Under: 510(k), Artificial Intelligence (AI), Big Data, Diagnostics, Digital Health, Electronic Medical Records (EMR), Featured, Food & Drug Administration (FDA), Health Information Technology, Health Technology, Machine Learning (ML), Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: FDA, Masimo

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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