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bioz dx hemodynamic monitor with philips 12-lead ecg model 5100
Cardiodynamics International
Summary: The bioz dx hemodynamic monitor is a non-invasive device used primarily for assessing cardiac hemodynamics. Key evidence highlights its utility in heart failure and atrial fibrillation patients.
FDA Clearance Information
Pathway
510K
Number
K070156 ↗
Decision Date
September 26, 2007
Product Code
DSB
Device Class
Class 2
Evidence
419 studies
The bioz dx hemodynamic monitor with Philips 12-lead ECG model 5100 was cleared by the FDA via the 510k pathway on September 26, 2007. It is manufactured by Cardiodynamics International and classified as a Class 2 device.
What It Is
The bioz dx hemodynamic monitor is a non-invasive device that utilizes impedance cardiography to assess cardiac hemodynamics. It is intended for use in clinical settings to monitor patients with cardiovascular conditions.
Clinical Applications
Commonly used in patients with heart failure and atrial fibrillation, the device provides valuable hemodynamic data that can aid in managing these conditions. It is particularly useful in ambulatory settings.
Evidence Summary
The available literature includes two studies published between 2019 and 2022. These studies explore the device's application in heart failure and atrial fibrillation, focusing on hemodynamic assessment and arterial stiffness.
Reported Outcomes
Published studies report that the bioz dx hemodynamic monitor effectively assesses cardiac hemodynamics in patients with heart failure and atrial fibrillation. It provides insights into arterial stiffness and its association with QTc interval prolongation.
Safety Profile
Reported complications include no specific adverse events directly linked to the use of the bioz dx hemodynamic monitor in the provided studies. The device is generally considered safe for non-invasive hemodynamic monitoring.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to validate findings and explore additional clinical applications.
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
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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
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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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
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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 bioz dx hemodynamic monitor?
The device is indicated for non-invasive assessment of cardiac hemodynamics, particularly in patients with heart failure and atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies have reported effective assessment of cardiac hemodynamics and insights into arterial stiffness and QTc interval prolongation.
What complications have been reported?
No specific complications have been reported in the provided studies, indicating a favorable safety profile.
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.