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philips dxl 12 16-lead ecg algorithm
Philips Medical Systems
Summary: The Philips DXL 12 16-lead ECG algorithm is a diagnostic tool used for interpreting ECGs, particularly in identifying myocardial infarctions. Key evidence suggests it aids in recognizing STEMI, though physician overreads remain more accurate.
FDA Clearance Information
Pathway
510K
Number
K132068 ↗
Decision Date
September 26, 2013
Product Code
DPS
Device Class
Class 2
Evidence
419 studies
The Philips DXL 12 16-lead ECG algorithm was cleared via the FDA 510(k) pathway on September 26, 2013. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The Philips DXL 12 16-lead ECG algorithm is a software tool designed to assist clinicians in the interpretation of electrocardiograms (ECGs). It is primarily used to identify cardiac events such as myocardial infarctions by analyzing ECG data.
Clinical Applications
This device is commonly used in emergency and cardiology departments to aid in the rapid diagnosis of conditions like ST-segment elevation myocardial infarction (STEMI). It provides a computerized interpretation that can support clinical decision-making.
Evidence Summary
The literature includes two studies evaluating the device's performance. These studies, published between 2016 and 2023, include a total of 927 patients and explore the algorithm's accuracy in detecting ischemic events.
Reported Outcomes
Published studies report that the Philips DXL algorithm is less accurate than physician overreads in identifying STEMI, but it remains a helpful tool in clinical practice. Another study demonstrated its comparable performance to expert manual analysis in detecting exercise-induced ischemia using QRS slopes.
Safety Profile
Reported complications include the potential for misinterpretation of ECG results, which could lead to incorrect clinical decisions. However, no specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to validate the algorithm's accuracy across diverse patient populations and clinical settings.
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 DXL 12 16-lead ECG algorithm?
The device is indicated for use in interpreting ECGs to identify cardiac events such as myocardial infarctions, particularly STEMI.
What outcomes have been reported in clinical studies?
Studies report that the algorithm aids in recognizing STEMI, though it is less accurate than physician overreads. It also performs comparably to expert analysis in detecting exercise-induced ischemia.
What complications have been reported?
Reported complications include potential misinterpretation of ECG results, but no specific adverse events were detailed in the studies.
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.