📊 Evidence-Based Reference
Philips Intellivue Guardiansoftware
Philips Medizin Systeme Boeblingen
Summary: Philips IntelliVue GuardianSoftware is a patient monitoring system designed for continuous surveillance in clinical settings. It is primarily used for detecting and alerting clinicians to potential cardiac arrhythmias. Key evidence highlights its usability and performance in hospital environments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161767 ↗
Decision Date ?
January 27, 2017
Product Code ?
DXJ
Device Class ?
Class 2
Evidence ?
419 studies
The Philips IntelliVue GuardianSoftware was cleared through the FDA 510(k) pathway on January 27, 2017. It is manufactured by Philips Medizin Systeme Boeblingen and is classified as a Class 2 device under product code DXJ.
What It Is
The Philips IntelliVue GuardianSoftware is a clinical monitoring system that provides continuous patient surveillance. It is intended for use in hospital settings to monitor vital signs and alert clinicians to potential issues such as cardiac arrhythmias.
FDA-Cleared Indications
- Continuous monitoring and surveillance of patients in clinical hospital settings.
- Analysis of patient-monitoring data to identify potential abnormalities.
- Generation of alerts to assist clinicians in recognizing possible cardiac arrhythmias and other changes in monitored patient status.
Clinical Applications
- Continuous surveillance of patients in intensive care and other hospital units.
- Monitoring patients whose vital signs require ongoing observation.
- Supporting clinician recognition of possible cardiac arrhythmias.
- Providing alerts when monitored data may indicate a change in patient condition.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and observational studies, conducted between 2021 and 2025. These studies evaluate the device's performance, usability, and safety in clinical settings.
Reported Outcomes
Published studies report that the Philips IntelliVue GuardianSoftware effectively detects cardiac arrhythmias and provides timely alerts to clinicians. Usability studies highlight its user-friendly interface, which enhances clinical workflow. Performance comparisons with other monitoring systems show competitive accuracy in alarm generation.
Safety Profile
Reported complications include concerns about alarm fatigue due to high false alarm rates, as noted in some studies. However, no significant adverse events directly attributed to the device's operation were documented.
Evidence Limitations
Evidence gaps include a need for more extensive studies on long-term outcomes and the impact of alarm fatigue on clinical decision-making. Some studies had limited sample sizes, which may affect the generalizability of findings.
Practical Considerations
- This is software used with compatible Philips IntelliVue monitoring hardware and hospital information-technology systems; compatibility should be confirmed before implementation.
- It is intended to support, not replace, clinical assessment and direct review of the patient or monitor data.
- The record describes a hospital monitoring system rather than an implanted or catheter-based device; it does not have patient body sizes, vascular access requirements, or anatomic deployment sites.
- MRI safety depends on the connected monitors, sensors, cables, and other equipment. The software itself should not be treated as an MRI-safe device without reviewing the complete system labeling.
- Alarm configuration, network connectivity, data quality, and staff response procedures affect safe use.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Philips IntelliVue GuardianSoftware?
The device is indicated for continuous monitoring of patient vitals and detection of cardiac arrhythmias in hospital settings.
What outcomes have been reported in clinical studies?
Studies report effective detection of cardiac arrhythmias and positive usability feedback from clinicians.
What complications have been reported?
Safety data indicate concerns about alarm fatigue due to false alarms, but no significant adverse events were reported.
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.