đź“Š Evidence-Based Reference
philips avalon fetal maternal monitors fm20 fm30 fm40 and fm50
Philips Medizinsysteme Boeblingen Gmbh, Cardiac An
Summary: The Philips Avalon Fetal Maternal Monitors (FM20, FM30, FM40, FM50) are devices used for monitoring fetal and maternal parameters during pregnancy and labor. Key evidence highlights their use in improving patient comfort and signal quality during prolonged monitoring.
FDA Clearance Information
Pathway
510K
Number
K111083 ↗
Decision Date
August 17, 2011
Product Code
HGM
Device Class
Class 2
Evidence
419 studies
The Philips Avalon Fetal Maternal Monitors were cleared by the FDA through the 510(k) pathway on August 17, 2011. Manufactured by Philips Medizinsysteme Boeblingen Gmbh, these devices are classified as Class 2 under product code HGM.
What It Is
The Philips Avalon Fetal Maternal Monitors are designed to track fetal heart rate and maternal uterine activity. They utilize noninvasive techniques to provide continuous monitoring, aiding in the assessment of fetal well-being and maternal health during labor.
Clinical Applications
These monitors are commonly used in labor and delivery settings to ensure fetal and maternal safety. They are particularly useful in scenarios requiring continuous monitoring, such as high-risk pregnancies or when non-reassuring fetal heart rate patterns are detected.
Evidence Summary
The available literature includes six studies, comprising various study types such as RCTs and prospective analyses, conducted between 2018 and 2025. These studies explore different aspects of fetal monitoring, including patient experience and device performance.
Reported Outcomes
Published studies report that the use of noninvasive fetal monitoring devices, like the Philips Avalon, can improve patient comfort and signal quality during prolonged monitoring. They also highlight differences in patient experiences based on the type of monitoring technology used.
Safety Profile
Reported complications include issues related to patient discomfort and signal interference. However, noninvasive methods are generally associated with fewer adverse events compared to invasive monitoring techniques.
Evidence Limitations
The evidence base is limited by a lack of large-scale, long-term studies directly comparing different monitoring technologies. Further research is needed to explore patient decision-making and the impact of monitoring on labor outcomes.
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 Avalon Fetal Maternal Monitors?
These monitors are indicated for continuous monitoring of fetal heart rate and maternal uterine activity during pregnancy and labor.
What outcomes have been reported in clinical studies?
Studies have reported improved patient comfort and signal quality with noninvasive monitoring, as well as differences in patient experiences based on the type of monitoring used.
What complications have been reported?
Reported complications include patient discomfort and signal interference, though noninvasive methods generally have fewer 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.