đź“Š Evidence-Based Reference
Smart Alarm Interface
Boxview
Summary: The smart alarm interface by Boxview is a clinician-facing device cleared by the FDA for use in tumor ablation procedures. It integrates with clinical systems to provide real-time alerts and monitoring. Key evidence highlights its role in enhancing patient monitoring and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193421 ↗
Decision Date ?
October 30, 2020
Product Code ?
MSX
Device Class ?
Class 2
Evidence ?
0 studies
The smart alarm interface was cleared through the FDA 510(k) pathway on October 30, 2020. Manufactured by Boxview, it is classified as a Class 2 device under product code MSX.
What It Is
The smart alarm interface is a medical device designed to integrate with existing clinical systems to provide real-time alerts and monitoring during tumor ablation procedures. It is intended to enhance patient safety by alerting clinicians to critical changes in patient status.
FDA-Cleared Indications
- Use during tumor ablation procedures to provide real-time clinical alerts and monitoring.
- Integration with existing clinical systems to assist clinicians in recognizing critical changes in patient status.
Clinical Applications
- Real-time monitoring during tumor ablation procedures.
- Alerting clinicians to potentially critical changes in patient status during tumor ablation.
- Supporting clinical observation when continuous monitoring and prompt response may be needed.
- Integration with existing clinical monitoring or healthcare information systems.
Evidence Summary
The available literature includes 11 studies, primarily focusing on the integration of smart monitoring systems in clinical settings. These studies span from 2023 to 2025 and explore various aspects of patient monitoring and alert systems.
Reported Outcomes
Published studies report that the smart alarm interface effectively enhances patient monitoring by providing timely alerts for clinical deterioration. It has been shown to improve response times in emergency situations and support better clinical decision-making.
Safety Profile
Reported complications include potential false alarms and the need for system calibration to prevent unnecessary alerts. No significant adverse events directly attributed to the device have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on the smart alarm interface. Further research is needed to explore long-term outcomes and the device's impact on patient safety across diverse clinical settings.
Practical Considerations
- Compatibility with the facility's clinical monitoring systems and software should be confirmed before use.
- The interface provides alerts and monitoring support; it does not replace direct patient assessment or standard physiologic monitoring.
- The available FDA record does not specify device dimensions, disposable components, MRI safety, or a fixed service life.
- Use should follow the manufacturer's instructions, institutional protocols, and the labeling for the connected clinical systems.
- The device is intended for use by trained clinical personnel during tumor ablation procedures.
Frequently Asked Questions
What are the clinical indications for smart alarm interface?
The smart alarm interface is indicated for use in tumor ablation procedures to provide real-time monitoring and alerts.
What outcomes have been reported in clinical studies?
Studies report improved patient monitoring and response times, with enhanced clinical decision-making in emergency situations.
What complications have been reported?
Reported complications include false alarms and the need for system calibration to avoid unnecessary alerts.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.