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philips holter analysis system
Philips Medizin Systeme Boblingen
Summary: The Philips Holter Analysis System is a diagnostic tool used for continuous cardiac monitoring. It is primarily used to assess heart rhythm abnormalities. Key evidence highlights its utility in evaluating cardiopulmonary risk and heart rate variability.
FDA Clearance Information
Pathway
510K
Number
K241890 ↗
Decision Date
March 21, 2025
Product Code
MLO
Device Class
Class 2
Evidence
419 studies
The Philips Holter Analysis System received FDA clearance through the 510(k) pathway on March 21, 2025. It is manufactured by Philips Medizin Systeme Boblingen and is classified as a Class 2 device.
What It Is
The Philips Holter Analysis System is a medical device designed for continuous monitoring of cardiac activity. It records heart rhythms over extended periods, aiding in the diagnosis of arrhythmias and other cardiac conditions.
Clinical Applications
This device is commonly used in outpatient settings for patients with suspected arrhythmias, unexplained syncope, or to evaluate treatment efficacy in known cardiac conditions. It provides valuable data for managing chronic cardiac diseases.
Evidence Summary
The available literature includes 15 studies, comprising randomized clinical trials and observational studies, published between 2024 and 2025. These studies explore various aspects of cardiac monitoring and its clinical implications.
Reported Outcomes
Published studies report that the Philips Holter Analysis System effectively identifies arrhythmias and contributes to the assessment of cardiopulmonary risk in COPD patients. It also aids in evaluating heart rate variability and its impact on clinical outcomes in heart failure patients.
Safety Profile
Reported complications include minor skin irritation from electrode placement and occasional data loss due to device malfunction. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up durations in some studies. Further research is needed to establish long-term outcomes and to compare its efficacy with other cardiac monitoring devices.
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 Holter Analysis System?
The device is indicated for continuous cardiac monitoring to detect arrhythmias and assess cardiopulmonary risk in various clinical scenarios.
What outcomes have been reported in clinical studies?
Studies have shown its effectiveness in identifying arrhythmias and assessing heart rate variability, contributing to improved management of cardiac conditions.
What complications have been reported?
Safety data indicate minor skin irritation and occasional data loss, but overall, the device is associated with a low risk of adverse events.
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.