Radius VSM and Accessories
Masimo CorporationRadius VSM and Accessories is a wearable multi-parameter patient monitor from Masimo Corporation designed for continuous monitoring of vital signs like heart rhythm, blood pressure, oxygen saturation, respiratory rate, and skin temperature. It helps clinicians monitor patients' cardiovascular and respiratory status in hospital settings and includes arrhythmia detection, facilitating timely clinical intervention and patient management.
Intended Use
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.
Technology
The device is a wearable, battery-operated, multi-modular patient monitor platform that scales different monitoring technologies such as SpO2, ECG, non-invasive blood pressure, pulse rate, plethysmography variability index (PVi), temperature, and respiration rate. The technology includes software features such as arrhythmia detection and mean arterial pressure (MAP) calculation derived from systolic and diastolic blood pressure.
Performance
Performance testing includes clinical validation of the newly added mean arterial pressure (MAP) feature against invasive MAP measurements using FDA-recognized ISO 81060-2 standard; bench testing with simulators; software verification and validation; and previous human factors testing supporting usability. No new biocompatibility, cybersecurity, wireless, or electrical safety testing was needed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/12/2025
2 months - 2
FDA Approval
5/29/2025
Other devices from Masimo Corporation
- Masimo W12025 • 510K
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